FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.

 - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B [Reserved]

    - Liquid crystal forehead temperature strip.
    - Bed-patient monitor.
    - Electronic monitor for gravity flow infusion systems.
    - Electrically powered spinal fluid pressure monitor.
    - Spinal fluid manometer.
    - Stand-on patient scale.
    - Patient scale.
    - Surgical sponge scale.
    - Image processing device for estimation of external blood loss.
    - Sterilization process indicator.
    - Clinical color change thermometer.
    - Clinical electronic thermometer.
    - Clinical mercury thermometer.
    - Apgar timer.

Subparts D-E [Reserved]

    - I.V. container.
    - Medical recirculating air cleaner.
    - Elastic bandage.
    - Liquid bandage.
    - AC-powered adjustable hospital bed.
    - Hydraulic adjustable hospital bed.
    - Manual adjustable hospital bed.
    - Infant radiant warmer.
    - Pediatric medical crib.
    - Medical bassinet.
    - Nonpowered flotation therapy mattress.

emergencies.
    - Examination gown.
    - Medical insole.
    - Implantable radiofrequency transponder system for patient identification and health information.
    - Ingestible event marker.
    - Medical device data system.
    - Remote Medication Management System.
    - AC-powered medical examination light.
    - Battery-powered medical examination light.
    - Patient lubricant.
    - Liquid medication dispenser.
    - Skin pressure protectors.
    - Medical ultraviolet air purifier.
    - Ultraviolet (UV) radiation chamber disinfection device.
    - Medical ultraviolet water purifier.
    - Body waste receptacle.
    - Vacuum-powered body fluid suction apparatus.
    - Protective restraint.
    - Powered patient transfer device.
    - Manual patient transfer device.
    - Washers for body waste receptacles.
    - Medical disposable scissors.
    - Sterilization wrap.
    - Ethylene oxide gas sterilizer.
    - Dry-heat sterilizer.
    - Steam sterilizer.
    - Liquid chemical sterilants/high level disinfectants.
    - Spore test strip.
    - General purpose disinfectants.
    - Hand-carried stretcher.
    - Wheeled stretcher.
    - Syringe needle introducer.
    - Irrigating syringe.
    - Liquid crystal vein locator.
    - Vein stabilizer.
    - Infusion stand.
    - Medical washer.
    - Medical washer-disinfector.     - Therapeutic medical binder.
    - Burn sheet.
    - Intravascular catheter.
    - Intravascular catheter securement device.
    - Medical adhesive tape and adhesive bandage.
    - Neonatal eye pad.
    - Medical absorbent fiber.
    - Neonatal incubator.
    - Neonatal transport incubator.
    - Pressure infusor for an I.V. bag.

 - Nonelectrically powered fluid injector.
    - Intravascular administration set.
    - Intravascular administration set, automated air removal system.
    - Patient care reverse isolation chamber.
    - Jet lavage.
    - AC-powered patient lift.
    - Non-AC-powered patient lift.
    - Alternating pressure air flotation mattress.
    - Temperature regulated water mattress.
    - Hypodermic single lumen needle.
    - Acupuncture needle.
    - Nipple shield.
    - Lamb feeding nipple.
    - Pediatric position holder.
    - Neonatal phototherapy unit.
    - Infusion pump.
    - Alternate controller enabled infusion pump.
    - Suction snakebite kit.
    - Chemical cold pack snakebite kit.
    - Medical support stocking.
    - Therapeutic scrotal support.
    - Piston syringe.
    - Umbilical occlusion device.
    - Lice removal kit.
    - Subcutaneous, implanted, intravascular infusion port and catheter.
    - Percutaneous, implanted, long-term intravascular catheter.

    - Absorbent tipped applicator.
    - Ice bag.
    - Medical disposable bedding.
    - Bed board.
    - Cardiopulmonary resuscitation board.
    - Hot/cold water bottle.
    - Ethylene oxide gas aerator cabinet.
    - Medical chair and table.
    - Ultrasonic cleaner for medical instruments.
   § 880.6175 - [Reserved]
    - Cast cover.
    - Mattress cover for medical purposes.
    - Ring cutter.
    - Sharps needle destruction device.
    - Tongue depressor.
    - Non-powdered patient examination glove.
    - Filtering facepiece respirator for use by the general public in public health medical 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

Extracted from US.FDA