Examples of General Medical Devices Classification

Examples of General Medical Devices Classification

Remarks:
  1. Local Responsible Person (LRP) may apply their general medical devices under risk class II/III/IV and in vitro diagnostic medical devices under risk class B/C/D for listing under the Medical Device Administrative Control System (MDACS). For details on application for listing, please refer to Medical Device Listing Application.
  2. The actual classification of a particular device must be considered individually, taking account of its design and use intended by the manufacturer. The above examples of medical devices are for reference only. Please refer to "Classification of General Medical Devices" (Technical Reference TR-003) and "Classification of In Vitro Diagnostic Medical Devices" (Technical Reference TR-006) for details.
  3. Where a medical device has features that place it into more than one class, classification should be based on the highest class indicated.
  4. If there is any inconsistency or ambiguity between the English version and the Chinese version, the English version shall prevail.

* AMDNS = Asian Medical Device Nomenclature System

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Risk Class IExpand
Risk Class I
AMDNS Code* AMDNS Term* Device Description
13375 Retractors, Surgical, Abdominal Wall Abdominal Wall Retractors
10211 Collection Containers, Aspirator/Suction Unit Aspirator Collection Containers
17417 Analyzers, Physiologic, Body Composition Body Fat Analyzers
37365 Breast Implant Sleeves Breast Implant Sleeves
15066 Swabs, Absorbent/Cotton Cotton Swabs
11315 Dressings Cotton Wool (Wound Dressing)
22945 Scissors, Surgical Dissecting Scissors (Reprocessable)
13698 Sponges, Surgical, Dissector Dissecting Sponges
34007 Electrodes, Neurologic, Evoked Potential Evoked Potential Neurologic Electrodes
12170 Tubing Sets, Intravenous Administration, Extension Extension Sets
12319 Fixed Loop Instruments, Surgical, Eye Lens Eye Lens Loops
12815 Ophthalmoscopes Funduscopes
16334 Analyzers, Physiologic, Neuromuscular Function, Gait Gait Analyzer
17649 Gastroplasty Bands Gastroplasty Bands
12157 Intravenous Administration Sets Infusion Kits
33198 Retractors, Surgical, Joint Tissue Joint Tissue Retractors
21410 Passers, Ligature Ligature Passers
25169 Bandages, Compression/Support, Multilayer Multilayer Compression Bandages
12726 Suture Needle Holding Instruments Needle Holders
16419 Cameras, Photographic, Ophthalmic Ophthalmic Cameras
16209 Forceps, Ophthalmic Ophthalmic Forceps
13517 Screwdrivers, Surgical, Bone/Bone Prosthesis Orthopedic Screwdrivers
14105 Traction Units Orthopedic Traction Hardware
12956 Baths, Paraffin, Physical Therapy Paraffin Baths
20255 Syringes, Plunger Piston Syringes
13373 Retractors Retractors
10284 Bandages, Compression/Support Self-Adherent Bandages
16262 Smoke Evacuation Systems, Surgical Smoke Evacuation Systems
33203 Retractors, Surgical, Spine Spine Retractors
13833 Stylets Stylets
33882 Drill Bits, Surgical Surgical Drill Bits
26685 Aspirator/Irrigators, Surgical Surgical Lavage Units
18606 Swabs, Specimen Collection/Transportation Transport Swabs
11265 Dilators, Urethral Urethral Dilators
13392 Retractors, Vaginal Vaginal Retractors
11073 Cuffs, Blood Pressure Blood Pressure Cuff
14449 Wheelchairs Wheelchairs
Risk Class IIExpand
Risk Class II
AMDNS Code* AMDNS Term* Device Description
12730 Needles, Acupuncture Acupuncture Needles
10123 Breathing Circuit Adapters Adapters
10046 Aerosol Generators Aerosol Generators
10139 Breathing Circuits, Anesthesia Anesthesia Breathing Circuits
28105 Topical Solution/Creams, Anesthetic Anesthetic Topical Solution
15982 Cannulae, Arthroscopy Drainage Arthroscopy Drainage Cannulae
10198 Arthroscopes Articular Cavity Endoscopes
10053 Artificial Airways Artificial Airways
13848 Suction Tips Aspirating Tips
10208 Aspirators Aspirator Compressors
15065 Suture Units, Automated Automated Suture Units
11712 Filters, Bacteria Bacteria Filters
12602 Monitors, Physiologic, Electroencephalography, Bedside Bedside EEG Monitors
10831 Choledochoscopes Biliary Tract Endoscopes
11330 Hand Drills, Biopsy Biopsy Drills
11775 Forceps, Biopsy Biopsy Forceps
10421 Blood Administration Sets Blood Administration/Transfusion Tubing
15171 Refrigerators, Blood Bank Blood Bank Refrigerators
23082 Centrifugal Blood Cell Processors Blood Cell Centrifuge
10446 Procedure Kit/Trays, Sampling, Blood Blood Collection Kits
12736 Needles, Blood Collection Blood Collection Kits
18242 Needles, Blood Collection, Protective Blood Collection Protective Needles
10689 Catheters, Vascular, Blood Pressure Blood Pressure Catheters
13106 Sphygmomanometers Blood Pressure Monitors
16173 Sphygmomanometers, Electronic, Automatic Blood Pressure Monitors
16833 Procedure Kit/Trays, Biopsy, Aspiration, Bone Marrow Bone Marrow Aspiration Biopsy Procedure Kit
10459 Bone Wax Bone Wax
10485 Aspirators, Breast Breast Pumps
10561 Cannulae Cannulae (General Use)
33885 Drill Bits, Surgical, Bone, Cannulated Cannulated Orthopedic Drill Bits
13361 Resuscitators, Cardiac Cardiac Resuscitators
17723 Monitoring Systems, Physiologic, Stress Exercise, Cardiac Cardiac Stress Exercise Monitoring Systems
34021 Catheter Introducers Catheter Introducers
12524 Dilators, Cervical Canal, Balloon Cervical Canal Balloon Dilators
26679 Aspirator/Irrigators, Colon Colon Lavage Units
18038 Corneal Topography Systems Computed Corneal Topography Systems
25725 Exercisers, Computer-Aided Training, Gait Computerized Gait Training Exercisers
27728 Exercisers, Computer-Aided Training, Upper Limb, Hand/Wrist Computerized Hand/Wrist Training Exercisers
26221 Exercisers, Computer-Aided Training, Neurologic Rehabilitation Computerized Neurologic Rehabilitation Training Exercisers
25726 Exercisers, Computer-Aided Training, Upper Limb Computerized Upper Limb Training Exercisers
10996 Contact Lenses Contact Lenses
17137 Exercisers, Continuous Passive Motion, Upper Limb, Hand/Wrist Continuous Passive Motion Hand/Wrist Exercisers
24766 Exercisers, Continuous Passive Motion, Lower Limb, Knee Continuous Passive Motion Knee Exercisers
17138 Exercisers, Continuous Passive Motion, Lower Limb Continuous Passive Motion Lower Limb Exercisers
24765 Exercisers, Continuous Passive Motion, Upper Limb, Shoulder Continuous Passive Motion Shoulder Exercisers
17139 Exercisers, Continuous Passive Motion, Upper Limb Continuous Passive Motion Upper Limb Exercisers
12701 Cannulae, Nasal, Continuous Positive Airway Pressure Continuous Positive Airway Pressure (CPAP) Cannulae
16534 Cryogenic Storage Containers Cryogenic Storage Containers
18051 Cryosurgical Units Cryoprobe
25701 Needles, Injection, Cystoscopic Cystoscopic Needles
16360 Orthodontic Brackets Dental/ Orthodontic Braces
16388 Dental Materials, Adhesive, Denture/Oral Tissue Denture Adhesives
13313 Refractors, Ophthalmic Dioptometers
39657 Clip Appliers, Laparoscopic, Disposable Disposable Laparoscopic Clip Appliers
17684 Clip Appliers, Vascular, Disposable Disposable Vascular Clip Appliers
22945 Scissors, Surgical Dissecting Scissors (Single Use)
17654 Duodenoscopes, Video Duodenoscopes
11407 Electrocardiographs ECG Machines
11467 Electroencephalographs EEG Machines
13450 Saws, Surgical, Bone, Electric Electrical Bone Saws
22123 Dermatomes, Electric Electrical Dermatomes
11439 Electrodes, Cardiac, Electrocardiography Electrocardiography Electrodes
16157 Sphygmomanometers, Electronic Electronic Sphygmomanometers
14032 Thermometers, Electronic Electronic Thermometers
34209 Stimulators, Electrical, Neuromuscular/Peripheral Nerve, Transcutaneous Electrotherapy Units
18424 Endoscope Sheaths Endoscope Sheaths
17424 Aspirator/Irrigators, Endoscopy Endoscopic Aspirator/Irrigators
17735 Suture Units, Automated, Endoscopy, Arthroscope Endoscopic Automated Suture Units
23523 Insufflators, Endoscopic Endoscopic Insufflators
41138 Scissors, Surgical, Endoscopic Endoscopic Scissors
23504 Endoscopic Telescopes Endoscopic Telescopes
17002 Cameras, Video, Endoscope Endoscopic video cameras
18034 Image Processors, Video, Endoscopy Endoscopic Video Image Processors
14085 Tubes, Tracheal Endotracheal Tubes
13209 Infusion Pumps, Enteral Feeding Enteric Pumps
10716 Catheters, Esophageal, Balloon Esophageal Balloon Catheters
11257 Dilators, Surgical, Esophageal, Endoscopic Esophageal Dilators
17986 Artificial Airways, Esophageal Obturation/Tracheal Esophageal Obturator Airways
13740 Sterilizing Units, Germicidal Gas, Ethylene Oxide Ethylene Oxide Sterilizers
12401 Lubricating Jellies Exam Gels
18702 Catheters, Biliary, Drainage, Percutaneous, External External Percutaneous Drainage Biliary Catheters
17680 Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal Extracorporeal Blood Gas/pH Monitors
32795 Hooks, Surgical, Eye Eye Hooks
27737 Topical Solution/Creams, Eye Lubrication Eye Lubrication Topical Solution
25702 Analyzers, Physiologic, Visual Function, Eye Structure Eye Structure Analyzers
27559 Knives, Surgical, Eye Eye Surgical Knives
28490 Dilators, Catheterization, Fascial Fascial Catheterization Dilators
27125 Tubes, Nasogastric, Feeding Feeding Tubes
27141 Tubes, Gastrostomy, Feeding Feeding Tubes
11696 Detectors, Fetal Heart, Ultrasonic Fetal Dopplers
17144 Cystoscopes, Flexible Flexible Cystoscopes
16268 Forceps, Biopsy, Flexible Endoscopic Flexible Endoscopic Biopsy Forceps
15075 Laryngoscopes, Flexible Flexible Laryngoscopes
15057 Sigmoidoscopes, Flexible Flexible Sigmoidoscopes
23491 Cystoscopes, Flexible, Video Flexible Video Cystoscopes
23531 Laryngoscopes, Flexible, Video Flexible Video Laryngoscopes
10720 Catheters, Urinary, Urethral, Drainage, Self-Retained Foley Catheters
41936 Footswitches Footswitches
17950 Warming Units, Patient, Forced-Air Forced-Air Hyperthermia Units
17888 Thermometers, Electronic, Infrared, Skin Forehead Thermometers
18108 Scanning Systems, Magnetic Resonance Imaging, Full-Body Full-Body Magnetic Resonance Imaging (MRI) Units
23486 Cameras, Photographic, Ophthalmic, Fundus, Non-Mydriatic Fundus Cameras
13366 Resuscitators, Pulmonary, Pneumatic Gas-Powered Resuscitators
18366 Recorders, Physiologic, pH, Upper Gastrointestinal Tract Gastroesophageal pH Recorders
25125 Snares, Gastrointestinal Tract, Endoscopic Gastrointestina Endoscopic Tract Snares
36607 Guide Wires, Gastroenterological Gastrointestinal Tract Guide Wires
24802 Manometers, Gastrointestinal Tract Gastrointestinal Tract Manometers
14221 Tubes, Nasogastric Gastrointestinal Tubes
11967 Hearing Aids Hearing Aids
15645 Humidifiers, Artificial Airway, Heat/Moisture Exchange Heat/Moisture Exchange Artificial Airway Humidifiers
12712 Nebulizers Heated Nebulizers
13586 Shunts, Arteriovenous Hemodialysis Shunt
39557 Oxygen Delivery Units, High-Flow High-Flow Oxygen Delivery Units
20740 Airway Clearance Units, High-Frequency Chest Wall Oscillation, Vest High-Frequency Chest Wall Oscillation Unit for sputum dislodge
12081 Hysteroscopes Hysteroscopes
17956 Warming Units, Patient, Radiant, Infant Infant Warmers
25786 Warming Units, Patient, Conductive Layer, Infant Infant Warmers
25473 Vein Finders, Infrared Light Infrared Light Vein Finders
23917 Phototherapy Units, Infrared Infrared Phototherapy Lamps
14036 Thermometers, Electronic, Infrared Infrared Thermometers
16579 Infusion Pump Administration Sets Infusion Pump Administration Sets
27894 Topical Solution/Cream/Gels, Injured Skin Injured Skin Topical Gels
12144 Insufflators Insufflators
24027 Needles, Injection, Hypodermic, Protective Intramuscular Needles
12745 Needles, Injection, Hypodermic Intramuscular Needles
12155 Intrauterine Balloons Intrauterine Balloons
16431 Catheters, Intrauterine Intrauterine Catheters
27338 Scanning Systems, Laser, Optical, Coherence, Tomography, Intravascular Intravascular Optical Tomography Laser Scanning Systems
13488 Scissors, Surgical, Eye, Iris Iris Scissors
15585 Procedure Kit/Trays, Irrigation/Lavage Irrigation tubes
12811 Ophthalmometers Keratometers
20485 Laparoscopes, Surgical Laparoscopes
32699 Trocars, Abdominal, Laparoscopic Laparoscopic Abdominal Trocars
26335 Cameras, Video, Laparoscopic Laparoscopic Video Cameras
26688 Aspirator/Irrigators, Laparoscopy Laparoscopy Lavage Units
27014 Artificial Airways, Laryngeal Mask Laryngeal Mask Artificial Airways
13845 Aspirator/Irrigators Lavage Units
18161 Germicides, Liquid Liquid Disinfectants (For Medical Device)
23744 Exercisers, Continuous Passive/Active Motion, Lower/Upper Limb Lower/Upper Limb Continuous Passive/Active Motion Machines
11729 Fittings/Adapters, Luer Luer Fittings
16260 Scanning Systems, Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) Units
17745 Catheters, Rectal, Manometric Manometric Rectal Catheters
16174 Sphygmomanometers, Electronic, Manual Manual Inflation Electronic Sphygmomanometers
18131 Distention Systems, Mechanical, Laparoscopic Mechanical Laparoscopic Distention Systems
12248 Knives, Surgical, Meniscus Meniscus Knives
11245 Microwave Therapy Systems, Diathermy Microwave Diathermy Therapy Systems
17432 Incubators, Infant, Mobile Mobile Infant Incubators
17433 Warming Units, Patient, Radiant, Infant, Mobile Mobile Infant Warmers
12699 Nasal Balloons Nasal Balloons
12700 Cannulae, Nasal, Oxygen Supply Nasal Oxygen Cannula
16798 Tubes, Nasoenteral, Feeding Nasoenteral Tubes
27109 Tubes, Nasoenteral Nasoenteral Tubes
10057 Artificial Airways, Nasopharyngeal Nasopharyngeal Artificial Airways
12710 Nasoscopes Nasoscopes
18069 Injectors, Medication/Vaccine, Needleless Needleless Injectors
12729 Needles Needles
18241 Blood Collection Needle Sets, Protective Needlestick Prevention Devices
10762 Catheters, Urinary, Urethral Nelaton Catheters
13775 Stimulators, Electrical, Neuromuscular Neuromuscular Electrical Stimulators (NMES)
18586 Nitric Oxide Delivery Units Nitric Oxide Delivery Units
24811 Ophthalmic Tonometers, Noncontact Noncontact Ophthalmic Tonometers
17428 Dressings, Synthetic, Film, Nonimpregnated Non-Impregnated Dressings
34872 Analyzers, Physiologic, Cardiovascular Function, Central Blood Pressure Non-invasive Aortic Blood Pressure Analyzers
24553 Aberrometers Ophthalmic Measuring Instruments
16809 Ophthalmic Tonometers Ophthalmic Tonometers
14035 Thermometers, Electronic, Thermistor/Thermocouple, Patient Oral Digital Thermometers
16472 Dispensers, Orthopedic Cement Orthopedic Cement Dispensers
36608 Guide Wires, Orthopedic Orthopedic Guide Wires
11331 Hand Drills, Surgical, Bone Orthopedic Hand Drills
13297 Reamers, Orthopedic Orthopedic Reamers
12448 Masks, Air-Oxygen Oxygen Inhalators
13538 Sensors, Oxygen Oxygen Sensors
15625 Papillotomes Papillotomes
24817 Dressings, Natural Fiber, Cotton/Gauze, Petrolatum Paraffin Dressings (non-medicated)
25208 Cooling Units, Patient, Circulating-Liquid Patient Circulating Liquid Cooling Units
36601 Guide Wires, Cardiovascular, Peripheral Peripheral Cardiovascular Guide Wires
34023 Catheter Introducers, Vascular, Peripheral Peripheral Vessel Catheter Introducers
16433 Catheters, Peritoneal Peritoneal Catheters
13037 Phototherapy Units Phototherapy Lamps
29200 Stimulators, Electrical, Neuromuscular, Physical Therapy/Massage Physical Therapy Electrotherapy Units
15662 Massage Machines, Physical Therapy Physical Therapy Massage Machines
15753 Transmitter/Receiver Systems, Physiologic Monitor Physiologic Monitor Transmitter/Receiver Systems
22129 Dermatomes, Pneumatic Pneumatic Dermatomes
34245 Polysomnographs, Portable Portable Sleep Recorders
16621 Pressure Monitoring Extension Tubing Sets Pressure Monitoring Extension Tubing Sets
17594 Probes, Pulse Oximeter Pulse Oximeter Probes
17148 Oximeters, Pulse Pulse Oximeters
13236 Pupillometers Pupillometers
18382 Bone Ultrasonometers Quantitative Ultrasound Densitometers
16247 Information Systems, Picture Archiving and Communication, Radiology Radiology Picture Archiving and Communication Systems (PACS)
16707 Dental Materials, Cement, Resin Composite Resin composite cements
24775 Flowmeters, Gas, Respiratory Respiratory Flowmeters
17698 Analyzers, Physiologic, Respiratory Function Mechanics Respiratory Function Analyzers
27759 Dental Materials, Restorative, Composite Resin, Light-Cured Restorative Dental Materials Light-Cured Composite Resin
18865 Lancets, Blood, Protective Safety Lancet
10909 Clips, Surgical, Vascular, Scalp Scalp Clips
27200 Blades, Surgical Scalpel Scalpel Blades
17825 Intravenous Administration Sets, Scalp-Vein Scalp-Vein Intravenous Administration Sets
18190 Ophthalmoscopes, Scanning Laser Scanning Laser Ophthalmoscope
15944 Cameras, Gamma Scintillation Cameras
24000 Catheters, Nasal, Sinus Dilatation, Endoscopic Sinus Dilatation Endoscopic Catheters
24906 Procedure Kit/Trays, Implant Delivery Sinus Lift Implant Delivery Kit
22691 Punches, Biopsy, Skin Skin Biopsy Punches
25226 Adhesive Strips, Wound Closure Skin Closure Adhesive Strip Bandages
35427 Hearing Aids, Skull Bone Vibration Skull Bone Vibration Hearing Aids
34010 Electrodes, Neurologic, Evoked Potential, Somatosensory Somatosensory Evoked Potential Neurologic Electrodes
18444 Scanning Systems, Gamma Camera, Single Photon Emission Computed Tomography SPECT scanners
13737 Sterilizing Units Sterilizers
16387 Manifolds, Stopcock Stopcock Manifolds
13803 Stopcocks Stopcocks
10749 Catheters, Tracheal, Suction Suction Catheters
16779 Tubing, Suction Suction Tubing
16420 Cannulae, Suprapubic Suprapubic Cannulae
10217 Aspirators, Surgical Surgical Aspirators
21368 Burs, Surgical Surgical Burs
11883 Gloves, Surgical Surgical Gloves
12754 Needles, Suture Surgical Suture Needles
13988 Monitors, Physiologic, Electrocardiography, Telemetric Telemetric ECG Monitors
13987 Monitors, Physiologic, Multipurpose, Telemetric Telemetric Physiologic Monitors
13782 Stimulators, Electrical, Peripheral Nerve, Analgesic, Transcutaneous TENS Stimulators
14161 Trocars, Thoracic Thoracic Trocars
33922 Hemostasis Pads Topical Hemostasis Pads
14082 Cuffs, Tracheal Tube Tracheal Tube Cuffs
17694 Tracheal Tube Introducers Tracheal Tube Introducers
14093 Tracheostomy Buttons Tracheostomy Buttons
26700 Tubes, Tracheostomy/Laryngectomy Tracheostomy/Laryngectomy Tubes
23418 Flowmeters, Blood, Ultrasonic, Transcranial Transcranial Ultrasonic Blood Flowmeters
12114 Incubators, Infant, Transport Transportable Infant Incubators
17940 Catheters, Transtracheal, Oxygen Supply Transtracheal Oxygen Supply Catheters
14141 Exercisers, Aerobic, Treadmill Treadmills
14154 Trocars Trocars
23840 Drill Bits Twist Drills
17887 Thermometers, Electronic, Infrared, Ear Tympanic Thermometers, Ear Thermometers
15756 Aspirator/Irrigators, Surgical, Ultrasonic Ultrasonic Aspirator/Irrigators
10432 Flowmeters, Blood, Ultrasonic Ultrasonic Blood Flowmeters
12719 Nebulizers, Ultrasonic Ultrasonic Nebulizers
14278 Scanning Systems, Ultrasonic Ultrasonic Scanners
11248 Ultrasound Therapy Systems, Physical Therapy Ultrasound Physical Therapy Units
15731 Phototherapy Units, Ultraviolet Ultraviolet Phototherapy Lamps
26652 Dilators, Ureteral, Access Sheath Ureteral Dilators
16468 Dilators, Surgical, Ureteral Ureteral Dilators
17690 Ureterorenoscopes Ureterorenoscopes
10764 Catheters, Urinary Urinary Drainage Tubes
14307 Urodynamic Measurement Systems Urodynamic Measurement Systems
16858 Ports, Vascular Access Vascular access port
24861 Scanning Systems, Ultrasonic, Vascular Access Vascular Access Ultrasonic Scanners
11268 Dilators, Surgical, Vascular Vascular Dilators
15003 Breathing Circuits, Ventilator Ventilator Breathing Circuits
12397 Vascular Loops Vessel Loops
14386 Vitrectomy Units Vitrectomy Units
18756 Catheters, Wound, Drainage Wound Drainage Catheters
Risk Class IIIExpand
Risk Class III
AMDNS Code* AMDNS Term* Device Description
10134 Anesthesia Units Anesthesia Machines
16068 Lenses, Intraocular, Anterior Chamber Anterior Chamber Intraocular Lenses (IOL)
16165 Prostheses, Gastroesophageal, Antireflux Antireflux Gastroesophageal Prostheses
12636 Monitoring Systems, Physiologic Arrhythmia Monitors
23406 Prostheses, Lower Limb, Knee Component Artificial Lower Limb Knee Component
23585 Prostheses, Nasal Artificial Nose
16405 Apheresis Units Automated Blood Component Separator
17116 Defibrillators, External, Automated Automated External Defibrillators
27890 Tourniquets, Pneumatic, Automated Automated Pneumatic Tourniquets
17605 Blood Cell Washer Sets, Autotransfusion Unit Autotransfusion Unit Blood Cell Washer Sets
17672 Stents, Biliary Biliary Stents
10426 Blood Donor Sets Blood Bags
12853 Oximeters Blood Gas Analyzers
10447 Warming Units, Blood/Intravenous Solution Blood Warmers
17537 Autotransfusion Units, Blood Processing Blood-Processing Autotransfusion Units
13050 Plates, Bone Bone Fixation Devices
16101 Screws, Bone Bone Screws
32734 Screws, Bone/Graft Bone/Graft Screws
26628 External Shock Wave Therapy Systems, Electromagnetic, Cardiac Cardiac Electromagnetic External Shock Wave Therapy Systems
11969 Heart-Lung Bypass Units Cardiopulmonary Bypass Units
17192 Radiographic/Fluoroscopic Systems, Cardiovascular Cardiovascular Radiographic/Fluoroscopic Systems
27995 Cataract Extraction Phacoemulsification/Vitrectomy Systems Cataract Extraction Units
17942 Oximeters, Cerebral Cerebral Oximeters
16972 Radiotherapy Systems, Cobalt Cobalt Radiotherapy Systems
18430 Radiographic Systems, Digital Computed Radiography Systems
17969 Injectors, Contrast Media, Computed Tomography Computed Tomography Contrast Media Injectors
13469 Scanning Systems, Computed Tomography Computed Tomography Scanning Systems
20161 Scanning Systems, Computed Tomography/Positron Emission Tomography Computed Tomography/Positron Emission Tomography Combined Systems
24311 Scanning Systems, Computed Tomography, Cone-Beam Cone Beam Computed Tomography Scanning Systems
17430 Cleaning Solutions, Contact Lens Contact Lens Cleaning Solutions
17431 Wetting Solutions, Contact Lens Contact Lens Wetting Solutions
23426 Hemodialysis Units, Renal, Continuous Replacement Therapy Continuous Renal Replacement Therapy Units
10985 Condoms Contraceptive Devices
17968 Injectors, Contrast Media Contrast Media Injectors
20352 Brachytherapy Systems Curietherapy Systems
17882 Defibrillator/Pacemakers, External Defibrillator/Monitors
33053 Defibrillator/Pacemaker/Physiologic Monitors Defibrillator/Pacemaker/Physiologic Monitors
29579 Defibrillators, External, Automated/Manual Defibrillators
16744 Dental Implants Dental Implants
29196 Radiofrequency Therapy Systems, Diathermy, Dermatologic Dermatologic Diathermy Units
11218 Hemodialysis Units Dialysis Machines
11490 Electrosurgical Units Diathermy Units
11500 Electrodes, Electrosurgical, Return Dispersive Electrodes
42070 Dressings, Combined, Composite, Absorbent, Antimicrobial Dressings (severe burns)
13143 Prostheses, Ear Auricle Ear Auricle Prostheses
11484 Stimulators, Electrical, Brain, Convulsive Therapy ECT Machines
34426 Monitors, Physiologic, Electroencephalography EEG Monitors
11418 Electrothermal Cautery Units Electrocautery Units
20863 Probes, Electrothermal Cautery Electrocautery Units Probes
15579 Electrodes, Electrosurgical Electrosurgical Electrodes
11499 Electrodes, Electrosurgical, Active, Hand-Controlled Electrosurgical Pencils
16206 Electrodes, Electrosurgical, Active, Foot-Controlled Electrosurgical Pencils
23653 Dental Implants, Endosteal Endosteal Dental Implants
17928 Stents, Esophageal Esophageal Stents
18499 Defibrillators, External External Defibrillators
15033 Electrodes, Cardiac, External Defibrillator External Defilbrillator Electrodes
33484 External Shock Wave Therapy Systems External Shock Wave Therapy Systems
13203 Pumps, Extracorporeal Perfusion Extracorporeal Perfusion Pumps
34428 Monitors, Physiologic, Fetal Fetal Monitors
18429 Radiographic Systems Fixed Radiographic Units
11279 Disinfectors, Liquid Germicide, Flexible Endoscope Flexible Endoscope Disinfecting Units
27308 Stereotactic Systems, Frame-Guided, Radiosurgical Frame-Guided Radiosurgical Stereotactic Systems
15956 Scanning Systems, Computed Tomography, Axial, Full-Body Full-Body Computed Tomography Scanning Systems
16885 Radiographic/Fluoroscopic Systems, General-Purpose General-Purpose Radiographic/Fluoroscopic Systems
20682 Water Purification Systems, Reverse Osmosis, Hemodialysis Hemodialysis Reverse Osmosis Systems
11232 Dialyzers, Hemodialysis Hemodialyzers
18166 Prostheses, Joint, Hip Hip Joint Implantable Prostheses
16485 Dialyzers, Hemodialysis, Hollow Fiber, High-Permeability Hollow Fiber Hemodialyzers
17423 Ventilators, Portable/Home Care Home Care Ventilators
18163 Germicides, Liquid, Hydrogen Peroxide Hydrogen Peroxide Sterilants
12061 Chambers, Treatment, Hyperbaric Hyperbaric chamber
27290 Stereotactic Systems, Image-Guided Image-Guided Stereotactic Systems
12324 Lenses, Intraocular Implantable Contact Lenses
21283 Clips, Implantable, Gastrointestinal Implantable Gastrointestinal Clips
16771 Staples Implantable Staples
16028 Clips, Implantable, Vascular Implantable Vascular Clips
16781 Procedure Kit/Trays, Catheterization, Urinary, Indwelling Indwelling Urinary Catheterization Kits
12113 Incubators, Infant Infant Warmers
16854 Ports, Injection/Infusion Infusion Port
20310 Syringes, Cartridge, Insulin, Penlike Insulin Pens
16588 Insulin Pump Administration Sets Insulin Pump Administration Sets
28074 Infusion Pumps, Insulin Insulin Pumps
16597 Radiographic/Fluoroscopic Systems, Angiography/Interventional Interventional X-ray/Fluoroscopic Systems
16230 Lithotripters, Intracorporeal, Impact, Ultrasonic Intracorporeal Ultrasonic Lithotripters
29717 Viscoelastic Solutions, Intraocular Intraocular Viscoelastic Solutions
16495 Infusion Pumps IV Pumps
16072 Prostheses, Joint, Knee Knee Joint Prostheses
28057 Infusion Pumps, Multitherapy, Large Volume Large Volume Multitherapy Infusion Pumps
17468 Lithotripters, Intracorporeal, Laser Laser Intracorporeal Lithotripters
23851 Ligament/Tendon Implants Ligament/Tendon Implants
12364 Radiotherapy Systems, Linear Accelerator Linacs
26629 Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator Linacs Radiosurgery Image-Guided Stereotactic Systems
16758 Lithotripters, Extracorporeal Lithotripters, Extracorporeal
18158 Injectors, Contrast Media, Magnetic Resonance Imaging Magnetic Resonance Imaging Contrast Media Injectors
18080 Condoms, External Male Condoms
12425 Radiographic Units, Mammography Mammography Units
23861 Augmentation/Reconstruction Implants, Facial Maxillofacial Implants
16048 Mesh, Metallic Metallic Mesh
22910 Sutures, Metallic Metallic Wire Sutures
16147 Prostheses, Middle Ear Ossicle Middle Ear Ossicle Prostheses
13272 Radiographic Units, Mobile Mobile X-Ray Units
22908 Sutures, Synthetic, Nonabsorbable, Nylon, Monofilament Monofilament Sutures
22904 Sutures, Synthetic, Nonabsorbable, Polyvinylidene Fluoride Homopolymer/Hexafluoropropylene Monofilament Sutures
13215 Infusion Pumps, Multitherapy Multitherapy Infusion Pumps
15868 Needle Guides Needle Guides
20395 Wound Therapy Systems, Negative-Pressure Negative-Pressure Wound Therapy Systems
34415 Monitors, Physiologic, Neonatal/Infant Neonatal Monitors
22899 Sutures, Synthetic, Nonabsorbable Nonabsorbable Sutures
12450 Masks, Air-Oxygen, Nonrebreathing Nonrebreathing Masks
23868 Augmentation/Reconstruction Implants, Facial, Nasal Nose Implant
12830 Orthopedic Cement Orthopedic Cement
16027 Orthopedic Internal Fixation Systems Orthopedic Internal Fixation Systems
16046 Orthopedic External Fixation Systems, Spinal Orthopedic Spinal External Fixation Systems
27299 Stereotactic Systems, Image-Guided, Surgical, Orthopedic Orthopedic Surgery Image-Guided Stereotactic Systems
12873 Oxygen Concentrators Oxygen Concentrators
17717 Stents, Pancreatic Pancreatic Stents
17588 Monitors, Physiologic, Patient Transport Patient Transport Monitors
16924 Infusion Pumps, Analgesic, Patient-Controlled Patient-Controlled Analgesia Units
11226 Peritoneal Dialysis Units Peritoneal Dialysis Cyclers
34411 Monitors, Physiologic Physiologic Monitors
18146 Sterilizing Units, Germicidal Gas, Gaseous Plasma Plasma Sterilizers
16071 Lenses, Intraocular, Posterior Chamber Posterior Chamber Intraocular Lenses (IOL)
20546 Radiotherapy Systems, Proton Beam Proton Beam Radiotherapy Systems
34610 Oximeters/Co-Oximeters, Pulse Pulse Oximeters/Co-Oximeters
34448 Monitors, Physiologic, Pulse Oximetry Pulse Oximetry Monitors
36782 Stents, Gastroduodenal Pyloric Stents
12327 Radiofrequency Therapy Systems, Tissue Ablation Radiofrequency Ablation Systems
11758 Radiographic/Fluoroscopic Units, Mobile Radiographic/Fluoroscopic C-arms
15952 Radiographic/Fluoroscopic Units Radiographic/Fluoroscopic Units
23717 Monitors, Physiologic, Respiration/Exhaled Carbon Dioxide/Pulse Oximetry, Bedside Respiration/Exhaled Carbon Dioxide/Pulse Oximetry Monitors
18599 Telemanipulation Systems, Surgical Robotic Surgical Systems
13468 Scanning Systems Scanning Systems
16099 Prostheses, Joint, Shoulder Shoulder Joint Prostheses
13910 Sutures, Natural, Nonabsorbable, Silk Silk Sutures
16045 Skin Expansion Implants Skin Expansion Implants
17985 Valves, Speech, Tracheoesophageal Speaking Valves
27296 Stereotactic Systems, Image-Guided, Surgical, Spinal Spinal Surgery Image-Guided Stereotactic Systems
13746 Sterilizing Units, Steam Steam Sterilizers
24901 Foot Implants, Subtarsal Subtarsal Foot Implants
25105 Stereotactic Systems, Image-Guided, Surgical Surgery Image-Guided Stereotactic Systems
20317 Staplers, Surgical Surgical Staplers
20328 Staples, Gastrointestinal/Internal Organ Surgical Staples
16142 Sterilizing Units, Steam, Tabletop Tabletop Steam Sterilizers
16102 Spacers, Tendon Tendon Spacers
13172 Testicle Implants Testicle Implants
16150 Prostheses, Joint, Hip, Total Total Hip Joint Prostheses
16096 Prostheses, Joint, Knee, Total Total Knee Joint Prostheses
18049 Ultrasonic Surgical Units Ultrasonic Coagulating Shears
16040 Stents, Ureteral Ureteral Stents
17889 Stents, Urethral Urethral C-Stents
13176 Prostheses, Urethral Sphincter Urethral Sphincter Prostheses
25126 Snares, Uterine, Endoscopic Uterine Endoscopic Tract Snares
37554 Vascular Closure Devices Vascular Closure Devices
17731 Occluders, Vascular Vascular Occluders
18098 Ventilators, Transport Ventilators
15613 Ventilators Ventilators
23930 Vessel Harvesting Systems Vessel Harvesting Systems
25209 Monitors, Physiologic, Vital Signs Vital Sign Monitor
17907 Infusion Pumps, Blood/Solution Warming Warming Blood/Solution Infusion Pumps
11315 Dressings Wound Dressings (for chronic ulcerated wounds)
26677 Irrigators, Wound Wound Irrigators
Risk Class IVExpand
Risk Class IV
AMDNS Code* AMDNS Term* Device Description
16791 Sponges, Hemostatic, Absorbable Absorbable Hemostatic Sponges (surgical use)
27284 Periodontal Regeneration Membrane Implants, Absorbable Absorbable Periodontal Regeneration Membrane Implants
22892 Sutures, Synthetic, Absorbable Absorbable Sutures
18679 Catheters, Cardiac, Angiography Angiographic Cardiac Catheters
17613 Catheters, Cardiac, Angiography, Ventricular Angiography Ventricular Catheters
17184 Catheters, Vascular, Angioplasty, Balloon Angioplasty Balloon Dilatation Catheters
16039 Annuloplasty Ring/Band Implants Annuloplasty Ring/Band Implants
42070 Dressings, Combined, Composite, Absorbent, Antimicrobial Antimicrobial Dressings
27750 Orthopedic Cement, Antimicrobial Antimicrobial Orthopedic Cement
26791 Catheters, Vascular, Stent Delivery, Aorta Aorta Stent Delivery Catheters
15768 Cannulae, Aortic Aortic Cannulae
33943 Procedure Kit/Trays, Implant Delivery, Cardiac Valve, Aortic Aortic Heart Valve Implant Delivery Kit
13177 Prostheses, Blood Vessel, Artificial Artificial Blood Vessels Prostheses
13138 Prostheses, Cardiac Valve Artificial heart valve
15869 Prostheses, Cardiac Valve, Artificial Artificial Heart Valves
18254 Grafts, Skin, Artificial Artificial Skin Grafts
20384 Stents, Vascular, Coronary, Balloon-Expandable, Bioactive-Coated Bioactive-Coated Stents
15870 Prostheses, Cardiac Valve, Biological Biological Heart Valve
37286 Bone Graft Substitutes Bone Graft Substitutes
15749 Cover Implants, Bur Hole Bur Hole Cover Implants
10561 Cannulae Cannulae (for neurological or cardiac use)
16655 Catheters, Cardiac, Electrophysiology, Ablation Cardiac Ablation Catheters
10840 Circulatory Assist Units, Cardiac Cardiac Assist Units
33296 Electrodes, Cardiac Cardiac Electrodes
18111 Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillator Cardiac Pacemaker/Defibrillator Lead Extraction Kits
12911 Pacemakers, Cardiac Cardiac Pacemakers
18610 Cardiac Wall Stabilizers Cardiac Tissue Stabilization Systems
16163 Procedure Kit/Trays, Cardioplegia Solution Administration Cardioplegia Delivery Sets
25708 Cardiovascular Patch Implants Cardiovascular Patch Implants
17797 Shunts, Carotid Artery Carotid Artery Shunts
34027 Catheter Introducers, Vascular, Central Venous, Directly Inserted Central Venous Catheter Introducers
18663 Catheters, Vascular, Hemodialysis, Central Venous Central Venous Hemodialysis Catheters
10729 Catheters, Vascular, Infusion, Central Venous Central Venous Infusion Catheters
10769 Catheters, Intracranial, Ventricular Cerebral Ventricular Drainage Catheters
41084 Hemostatic Agents, Surgical, Collagen Collagen Hemostatic Agents
24190 Mesh, Collagen Collagen Mesh
15284 Injectors, Contrast Media, Angiography Contrast Media Angiography Injectors
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary Coronary Angioplasty Balloon Dilatation Catheters
33507 Stents, Vascular, Coronary, Bifurcation Coronary Bifurcation Stents
36600 Guide Wires, Cardiovascular, Coronary Coronary Vessel Guide Wires
23860 Augmentation/Reconstruction Implants Cosmetic Implants
13052 Plates, Cranioplasty Cranioplasty Plates
20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting Drug-Eluting Coronary Stents
23846 Dura Mater Implants Dura Mater Implants
18466 Stimulators, Electrical Electrical Stimulators
10714 Catheters, Vascular, Embolectomy/Thrombectomy Embolectomy/Thrombectomy Catheters
12900 Leads, Implantable Cardiac Pacemaker, Endocardial Endocardial Implantable Cardiac Pacemaker Leads
20454 Stent/Grafts, Vascular, Aortoiliac Endovascular Stent Grafts
16989 Leads, External Cardiac Pacemaker, Myocardial External Cardaic Pacemaker Myocardial Electrodes
22556 Leads, External Cardiac Pacemaker External Cardiac Pacemaker Leads
16654 Catheters, Cardiac, Flotation Balloon, Pacing Electrode Flotation Balloon Cardiac Catheters with Pacing Electrodes
41085 Hemostatic Agents, Surgical, Gelatin Gelatin Hemostatic Agents
13379 Retractors, Surgical, Thoracic Organ, Heart Heart Retractors
15012 Heart-Lung Bypass Unit Tubing Sets Heart-Lung Bypass Unit Tubing Sets
15022 Catheters, Vascular, Hemodialysis Hemodialysis Catheters
33055 Stents, Vascular, Peripheral, Balloon-Expandable, Iliac Iliac Stents
16652 Defibrillators, Implantable Implantable Defibrillator
16653 Leads, Implantable Defibrillator Implantable Defibrillator Leads
14174 Clips, Implantable, Fallopian Tube Implantable Fallopian Tube Clips
18637 Catheters, Vascular, Infusion Infusion Vascular Catheters
23150 Interbody Spinal Fusion Implants Interbody Spinal Fusion Implants
12913 Pacemakers, Cardiac, Implantable Internal Cardiac Pacemaker
18569 Viscoelastic Solutions, Intraarticular Intraarticular Viscoelastic Solutions
32030 Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery Intracranial Artery Angioplasty Balloon Dilatation Catheters
28243 Stents, Vascular, Intracranial Artery Intracranial Artery Stents
18695 Catheters, Intracranial Intracranial Catheters
12156 Intrauterine Devices, Contraceptive Intrauterine Devices
15034 Occluders, Vascular, Intravascular Embolization Intravascular Embolization Devices
37580 Sutures, Synthetic, Absorbable, Polyhydroxybutyrate, Monofilament Monofilament Sutures
22903 Sutures, Synthetic, Nonabsorbable, Polyester, Multifilament Multifilament Sutures
16057 Nerve Sheath Implants Nerve Sheath Implants
18640 Catheters, Vascular, Infusion, Central Venous, Percutaneous Percutaneous Central Venous Catheters
34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery Peripheral Artery Angioplasty Balloon Dilatation Catheters
10742 Catheters, Peritoneal, Dialysis Peritoneal Dialysis Catheters
17471 Sutures, Synthetic, Absorbable, Polyglactin Polyglactin Sutures
16777 Catheters, Cardiac, Flotation Balloon, Pulmonary Artery Pulmonary Artery Flotation Balloon Catheters
23844 Breast Implants, Saline-Filled Saline-Filled Breast Implants
17855 Breast Implants, Gel-Filled Silicone Gel-Filled Breast Implants
18084 Spacers Spacers
15971 Sutures, Metallic, Stainless Steel, Monofilament Stainless Steel Monofilament Sutures
13911 Sutures, Metallic, Stainless Steel Stainless Steel Sutures
26140 Hemostatic Agents, Surgical Surgical Hemostatic Agents
17693 Procedure Kit/Trays, Implant Delivery, Stent, Ureter Ureteral Stent Implant Procedure Kits
10764 Catheters, Urinary Urinary Drainage Tubes
34022 Catheter Introducers, Vascular Vascular Catheter Introducers
18636 Catheters, Vascular Vascular Catheters
17846 Catheters, Vascular, Guiding Vascular Guiding Shealth
17461 Stents, Vascular Vascular Stents