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).

    - Air or water caloric stimulator.

    - Surgical nerve stimulator/locator.
    - Toynbee diagnostic tube.

Subpart C [Reserved]

    - Hearing Aid.
    - Wireless air-conduction hearing aid.
    - Hearing aid calibrator and analysis system.
    - Tympanic membrane contact hearing aid.
    - Group hearing aid or group auditory trainer.
    - Self-fitting air-conduction hearing aid.
    - Master hearing aid.
    - Active implantable bone conduction hearing system.
    - Battery-powered artificial larynx.
    - Tinnitus masker.
    - Middle ear mold.
    - Partial ossicular replacement prosthesis.
    - Total ossicular replacement prosthesis.
    - Prosthesis modification instrument for ossicular replacement surgery.
    - Ear, nose, and throat synthetic polymer material.
    - Mandibular implant facial prosthesis.
    - Laryngeal prosthesis (Taub design).
    - Sacculotomy tack (Cody tack)
    - Endolymphatic shunt.
    - Endolymphatic shunt tube with valve.
    - Tympanostomy tube.
    - Nasal dilator.
    - Tympanostomy tube with semipermeable membrane.
    - Transcutaneous air conduction hearing aid system.

    - Epistaxis balloon.
    - Ear, nose, and throat bur.
    - Nasopharyngeal catheter.
    - Eustachian tube balloon dilation system.
    - Ear, nose, and throat electric or pneumatic surgical drill.
    - Ear, nose, and throat fiberoptic light source and carrier.
    - Ear, nose, and throat manual surgical instrument.
    - Argon laser for otology, rhinology, and laryngology.
    - Ear, nose, and throat microsurgical carbon dioxide laser.
    - Bronchoscope (flexible or rigid) and accessories.
    - Esophagoscope (flexible or rigid) and accessories.
    - Mediastinoscope and accessories.
    - Laryngostroboscope.
    - Nasopharyngoscope (flexible or rigid) and accessories.

    - Otoscope.
    - Intranasal splint.
    - Bone particle collector.

    - Ear, nose, and throat drug administration device.
    - Ear, nose, and throat examination and treatment unit.
    - Suction antichoke device.
    - Tongs antichoke device.
    - Powered nasal irrigator.
    - External nasal splint.
    - Antistammering device.
    - External upper esophageal sphincter compression device.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

Extracted from US.FDA