| 3D printed patient-specific anatomic models | | 3D printed patient-specific anatomic models | | Class I
|
| 3D Surgical Instruments | | 3D Surgical Instruments | | Class I
|
| 4-dot binocular vision test | | 4-dot binocular vision test | | Class I Devices |
| A heat reflective jacket designed to prevent hypothermia and shock | | A heat reflective jacket designed to prevent hypothermia and shock | | Class I
|
| A radiant heat reflective emergency bag to treat shock and hypothermia | | A radiant heat reflective emergency bag to treat shock and hypothermia | | Class I
|
| A1 | | Measuring and mixing devices for medicines | | Class I Devices |
| A1 | | Measuring Cups/Spoons/Droppers | | Class I Devices |
| A1 | | Medical measuring dosage spoons and oral dosage syringes | | Class I Devices |
| A1 | | Medical measuring dosage spoons and oral dosage syringes | | Class I Devices |
| A2 | | Inhalation Devices (E.G. Chamber Spacers) | | Class I Devices |
| A2 | | Inhalation Devices (E.G. Chamber Spacers) | | Class I Devices |
| A3 | | Sets - Solution/Irrigation (Gravity Only) | | Class I Devices |
| A3 | | Sets - Solution/Irrigation (Gravity Only) | | Class I Devices |
| A4 | | Syringes (Hypodermic/Oral/Irrigation) | | Class I Devices |
| A4 | | Syringes (Hypodermic/Oral/Irrigation) | | Class I Devices |
| A5 | | Dispensers (Cement, Etc.) And Accessories | | Class I Devices |
| A5 | | Dispensers (Cement, Etc.) And Accessories | | Class I Devices |
| A6 | | Sensitivity Testing Devices | | Class I Devices |
| A7 | | Non-Active Autoinjector Devices | | Class I Devices |
| A7 | | Non-Active Autoinjector Devices | | Class I Devices |
| A8 | | Non-Active Infusion Devices And Accessories | | Class I Devices |
| A8 | | Non-Active Infusion Devices And Accessories | | Class I Devices |
| Abdominal aorta endovascular stent-graft | | Abdominal aorta endovascular stent-graft | | Custom Made Devices |
| Abdominal binder reusable | | Abdominal binder reusable | |
|
| Abdominal binder reusable | | Abdominal binder reusable | | Class I
|
| Abdominal decompression chamber pump | | Abdominal decompression chamber pump | |
|
| Abdominal hernia truss reusable | | Abdominal hernia truss reusable | |
|
| Abdominal hernia truss reusable | | Abdominal hernia truss reusable | | Class I
|
| Abdominal public health screening x-ray system | | Abdominal public health screening x-ray system | |
|
| Abdominal scissors | | Abdominal scissors | | Class I
|
| Abdominal/intestinal spatula | | Abdominal/intestinal spatula | | Class I
|
| Abrasive Skin Preparation Tabs | | Abrasive Skin Preparation Tabs | | Class I
|
| Absorbent tipped applicator non-sterile | | Absorbent tipped applicator non-sterile | | Class I
|
| Absorbent tipped applicator, non-sterile | | Absorbent tipped applicator, non-sterile | | Class I Devices |
| Absorbent tipped applicator, non-sterile | | Absorbent tipped applicator, non-sterile | | Class I Devices |
| Absorbent tipped applicator, sterile | | Absorbent tipped applicator, sterile | | Class I Devices |
| Absorbent underpad | | Absorbent underpad | | Class I Devices |
| Absorbent underpad | | Absorbent underpad | | Class I
|
| Absorbent underpad, non-sterile | | Absorbent underpad, non-sterile | | Class I Devices |
| Absorbent wound compression pad | | Absorbent wound compression pad | |
|
| Absorbent wound compression pad | | Absorbent wound compression pad | | Class I
|
| Accessories For Implantable Devices (Non-Invasive) | | Accessories For Implantable Devices (Non-Invasive) | | Class I
|
| Accessory, bite block, for endoscope | | Accessory, bite block, for endoscope | | Class I Devices |
| Acetabular augmentation implant | | Acetabular augmentation implant | |
|
| Acetabular orthopaedic reamer | | Acetabular orthopaedic reamer | |
|
| Acetabular orthopaedic reamer | | Acetabular orthopaedic reamer | | Class I
|
| Acetabular shell | | Acetabular shell | |
|
| Acetabulum prosthesis hole plug | | Acetabulum prosthesis hole plug | |
|
| Acetabulum prosthesis trial reusable | | Acetabulum prosthesis trial reusable | |
|
| Acetabulum prosthesis trial reusable | | Acetabulum prosthesis trial reusable | | Class I
|
| Acoustic earmuffs | | Acoustic earmuffs | |
|
| Active-support bandage | | Active-support bandage | | Class I Devices |
| Active Cables | | Active Cables | | Class I
|
| Active Medical Device Accessories (e.g. batteries chargers power supply units) | | Active Medical Device Accessories (e.g. batteries chargers power supply units) | | Class I
|
| Acupressure applicator reusable | | Acupressure applicator reusable | | Class I
|
| Acupressure Devices and Copper Bracelets | | Acupressure Devices and Copper Bracelets | | Class I
|
| Acupressure wristband | | Acupressure wristband | | Class I
|
| Acupuncture electrical stimulation system | | Acupuncture electrical stimulation system | |
|
| Acupuncture electrical stimulation system | | Acupuncture electrical stimulation system | | Class I
|
| Adenoid curette reusable | | Adenoid curette reusable | | Class I
|
| Adenoid punch forceps | | Adenoid punch forceps | | Class I
|
| Adhesive bandage | | Adhesive bandage | | Class I Devices |
| Adhesive bandage | | Adhesive bandage | |
|
| Adhesive bandage | | Adhesive bandage | | Class I
|
| Adhesive Plasters/Dressings/Tapes/Barrier Films | | Adhesive Plasters/Dressings/Tapes/Barrier Films | | Class I
|
| Adhesive Plate Cables Footswitches | | Adhesive Plate Cables Footswitches | | Class I
|
| Adhesive tape, | | Adhesive tape, | | Class I Devices |
| Adhesive | | Adhesive | | Class I Devices |
| Adjustable Chairs | | Adjustable Chairs | | Class I
|
| Adjustor-Pro Chiropractic Adjusting Instrument EL | | Adjustor-Pro Chiropractic Adjusting Instrument EL | | Class I
|
| Adjustor Pro - Chiropractic Adusting Instrument | | Adjustor Pro - Chiropractic Adusting Instrument | | Class I
|
| Administration Device | | Administration Device | | Class I
|
| Administrative risk-management information system application software | | Administrative risk-management information system application software | | Class I
|
| Adult drinking/feeding cup | | Adult drinking/feeding cup | | Class I
|
| Adult inguinal hernia truss | | Adult inguinal hernia truss | | Class I
|
| Adult nappy | | Adult nappy | | Class I Devices |
| Adult nappy | | Adult nappy | | Class I
|
| Adult whole-body immobilizer | | Adult whole-body immobilizer | | Class I Devices |
| Aerosol face mask non-rebreathing | | Aerosol face mask non-rebreathing | | Class I
|
| Aerosol face mask rebreathing | | Aerosol face mask rebreathing | | Class I
|
| Aerosol face mask, rebreathing | | Aerosol face mask, rebreathing | | Class I Devices |
| Affective disorder therapy software | | Affective disorder therapy software | |
|
| Affective disorder therapy software | | Affective disorder therapy software | | Class I
|
| Agar dental impression material | | Agar dental impression material | |
|
| Aids For Daily Living (Bathing And Toilet) | | Aids For Daily Living (Bathing And Toilet) | | Class I
|
| Aids For Daily Living (Other) | | Aids For Daily Living (Other) | | Class I
|
| Aids For Daily Living (Seating And Support) | | Aids For Daily Living (Seating And Support) | | Class I
|
| Air-filled bed mattress overlay | | Air-filled bed mattress overlay | | Class I
|
| Air-filled chair cushion | | Air-filled chair cushion | | Class I
|
| Airway Devices/Monitoring Equipment And Accessories | | Airway Devices/Monitoring Equipment And Accessories | | Class I
|
| Airway emergency clearance/suction plunger | | Airway emergency clearance/suction plunger | | Class I
|
| Airway obstruction forceps | | Airway obstruction forceps | | Class I
|
| Airway pressure alarm | | Airway pressure alarm | | Class I
|
| Airway pressure monitor non-powered | | Airway pressure monitor non-powered | |
|
| Airway pressure/oxygen monitor | | Airway pressure/oxygen monitor | | Class I Devices |
| Airway suction catheter | | Airway suction catheter | | Class I
|
| Airway tube forceps reusable | | Airway tube forceps reusable | | Class I
|
| Airway tube forceps single-use | | Airway tube forceps single-use | | Class I
|
| Airway, | | Airway, | | Class I Devices |
| Alarm application software | | Alarm application software | | Class I
|
| Alcohol Preparation Pads For Use For General Cleaning On Unbroken Skin (Not Measurable) | | Alcohol Preparation Pads For Use For General Cleaning On Unbroken Skin (Not Measurable) | | Class I
|
| Alcohol Wipes | | Alcohol Wipes | | Class I
|
| Alginate dental impression material | | Alginate dental impression material | |
|
| Alginate dental impression material | | Alginate dental impression material | | Class I
|
| Alkaline Detergent 9012 | | Alkaline Detergent 9012 | | Class I
|
| Allergen Resistant Bedding | | Allergen Resistant Bedding | | Class I
|
| Alternating-pressure bed mattress overlay system | | Alternating-pressure bed mattress overlay system | | Class I
|
| Alternating-pressure bed mattress overlay system | | Alternating-pressure bed mattress overlay system | | Class I Devices |
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | | Class I Devices |
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | |
|
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | | Class I
|
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | | Class I Devices |
| Alternating-pressure bed mattress | | Alternating-pressure bed mattress | | Class I
|
| Alternating-pressure chair cushion reusable | | Alternating-pressure chair cushion reusable | | Class I
|
| Alternating-pressure chair cushion system | | Alternating-pressure chair cushion system | | Class I
|
| Alternating-pressure pump | | Alternating-pressure pump | | Class I
|
| Ambulatory recorder conductive patch | | Ambulatory recorder conductive patch | | Class I Devices |
| Amniotic membrane perforator reusable | | Amniotic membrane perforator reusable | | Class I
|
| Amniotic membrane perforator single-use | | Amniotic membrane perforator single-use | | Class I
|
| Amniotic trocar | | Amniotic trocar | | Class I Devices |
| Amniotome reusable | | Amniotome reusable | | Class I
|
| Amputation knife | | Amputation knife | | Class I
|
| Anaesthesia administration patient evaluation software | | Anaesthesia administration patient evaluation software | | Class I
|
| Anaesthesia administration support software | | Anaesthesia administration support software | |
|
| Anaesthesia breathing circuit single-use | | Anaesthesia breathing circuit single-use | | Class I
|
| Anaesthesia conduction filter | | Anaesthesia conduction filter | | Class I
|
| Anaesthesia face mask reusable | | Anaesthesia face mask reusable | | Class I
|
| Anaesthesia face mask single-use | | Anaesthesia face mask single-use | | Class I
|
| Anaesthesia information system application software | | Anaesthesia information system application software | |
|
| Anaesthesia kit, epidural | | Anaesthesia kit, epidural | | Class I Devices |
| Anaesthesia mask strap reusable | | Anaesthesia mask strap reusable | | Class I
|
| Anaesthesia mask strap single-use | | Anaesthesia mask strap single-use | | Class I
|
| Anaesthesia screen | | Anaesthesia screen | | Class I
|
| Anaesthesia workstation gas scavenger | | Anaesthesia workstation gas scavenger | | Class I
|
| Anaesthetic devices and accessories | | Anaesthetic devices and accessories | | Class I
|
| Anaesthetic gas scavenging unit | | Anaesthetic gas scavenging unit | | Class I Devices |
| Anaesthetic Sundries | | Anaesthetic Sundries | |
|
| Analgesic PENS system probe single-use | | Analgesic PENS system probe single-use | |
|
| Analgesic percutaneous electrical nerve stimulation system | | Analgesic percutaneous electrical nerve stimulation system | |
|
| Analgesic TENS system | | Analgesic TENS system | | Class I Devices |
| Analgesic TENS system | | Analgesic TENS system | | Class I Devices |
| Analytical non-scalp cutaneous electrode | | Analytical non-scalp cutaneous electrode | | Class I
|
| Analytical scalp electrode single-use | | Analytical scalp electrode single-use | | Class I
|
| Analytical scalp electrode, reusable | | Analytical scalp electrode, reusable | | Class I Devices |
| Analytical scalp electrode, single-use | | Analytical scalp electrode, single-use | | Products Covered By Article 12 |
| Aneroid manual sphygmomanometer | | Aneroid manual sphygmomanometer | | Class I Devices |
| Aneroid manual sphygmomanometer | | Aneroid manual sphygmomanometer | | Class I
|
| Aneurysm clip applier | | Aneurysm clip applier | | Class I
|
| Angiographic drape | | Angiographic drape | | Class I Devices |
| Angiographic syringe | | Angiographic syringe | | Class I Devices |
| Angiographic x-ray system application software | | Angiographic x-ray system application software | | Class I
|
| Angiography kit | | Angiography kit | |
|
| Angioplasty catheter connector | | Angioplasty catheter connector | | Class I Devices |
| Ankle-disarticulation prosthesis socket | | Ankle-disarticulation prosthesis socket | |
|
| Ankle-disarticulation prosthesis | | Ankle-disarticulation prosthesis | |
|
| Ankle binder reusable | | Ankle binder reusable | | Class I
|
| Ankle joint orthosis | | Ankle joint orthosis | |
|
| Ankle joint orthosis | | Ankle joint orthosis | | Class I
|
| Ankle prosthesis bearing | | Ankle prosthesis bearing | |
|
| Ankle prosthesis trial | | Ankle prosthesis trial | |
|
| Ankle/foot orthosis | | Ankle/foot orthosis | |
|
| Ankle/foot orthosis | | Ankle/foot orthosis | | Class I
|
| Ankle/foot prosthesis | | Ankle/foot prosthesis | | Class I Devices |
| Anorectal lubrication dressing | | Anorectal lubrication dressing | | Class I
|
| Anorectal mucosa suppository | | Anorectal mucosa suppository | | Class I
|
| Anorectal mucosa suppository | | Anorectal mucosa suppository | | Class I Devices |
| Anoscope single-use | | Anoscope single-use | | Class I
|
| Anoscope, single-use | | Anoscope, single-use | | Class I Devices |
| Anterior-chamber intraocular lens phakic | | Anterior-chamber intraocular lens phakic | | Class I
|
| Anterior-chamber intraocular lens pseudophakic | | Anterior-chamber intraocular lens pseudophakic | | Class I
|
| Anterior head supports/ neck braces/ cervical collars | | Anterior head supports/ neck braces/ cervical collars | | Class I
|
| Anterior/posterior segment scissors reusable | | Anterior/posterior segment scissors reusable | | Class I
|
| Anti-suffocation pillow | | Anti-suffocation pillow | | Class I
|
| Anti - Suffocation Pillow | | Anti - Suffocation Pillow | | Class I
|
| Anti Motion Sickness Ear Plug | | Anti Motion Sickness Ear Plug | | Class I
|
| Antibacterial screen protector | | Antibacterial screen protector | | Class I Devices |
| Antimicrobial absorbent underpad, non-sterile | | Antimicrobial absorbent underpad, non-sterile | | Class I Devices |
| Antimicrobial absorbent underpad, non-sterile | | Antimicrobial absorbent underpad, non-sterile | | Class I Devices |
| Antimicrobial bed mattress cover | | Antimicrobial bed mattress cover | | Class I Devices |
| Antimicrobial bed mattress cover | | Antimicrobial bed mattress cover | | Class I Devices |
| Antimicrobial glove/mitten | | Antimicrobial glove/mitten | | Class I Devices |
| Antimicrobial glove/mitten | | Antimicrobial glove/mitten | | Class I
|
| Antimicrobial glove/mitten | | Antimicrobial glove/mitten | | Class I Devices |
| Antimicrobial soft corrective contact lens daily-disposable | | Antimicrobial soft corrective contact lens daily-disposable | | Class I
|
| Antimicrobial soft corrective contact lens daily-wear | | Antimicrobial soft corrective contact lens daily-wear | | Class I
|
| Antimicrobial surgical respirator | | Antimicrobial surgical respirator | | Class I Devices |
| Antimicrobial wound irrigation solution non-sterile | | Antimicrobial wound irrigation solution non-sterile | | Class I
|
| Antiseptic swab | | Antiseptic swab | | Class I Devices |
| Antiseptic towelette | | Antiseptic towelette | | Class I
|
| Antisnoring device | | Antisnoring device | | Class I
|
| Antisnoring mucosa lubricant | | Antisnoring mucosa lubricant | | Class I
|
| Apparatus, suction, patient care | | Apparatus, suction, patient care | | Class I Devices |
| Appetite-suppression gastric balloon | | Appetite-suppression gastric balloon | |
|
| Appliance, colostomy, disposable | | Appliance, colostomy, disposable | | Class I Devices |
| Applicator Brush (Dental Use) | | Applicator Brush (Dental Use) | | Class I
|
| Applicator tips brushes and mixing tips | | Applicator tips brushes and mixing tips | | Class I
|
| Applicator, | | Applicator, | | Class I Devices |
| Apron, leaded | | Apron, leaded | | Class I Devices |
| Apron, | | Apron, | | Class I Devices |
| Aquamax body wash | | Aquamax body wash | | Class I
|