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).

    - Speculum and accessories.

Subpart C [Reserved]

    - External facial fracture fixation appliance.
    - Surgical mesh.
    - Polytetrafluoroethylene with carbon fibers composite implant material.
    - Carbon dioxide gas controlled tissue expander.
    - Silicone inflatable breast prosthesis.
    - Silicone gel-filled breast prosthesis.
    - Chin prosthesis.
    - Ear prosthesis.
    - Esophageal prosthesis.
    - Nose prosthesis.
    - Tracheal prosthesis.
    - External prosthesis adhesive.
    - External aesthetic restoration prosthesis.
    - Inflatable extremity splint.
    - Noninflatable extremity splint.
    - Plastic surgery kit and accessories.

    - Tissue adhesive.
    - Tissue adhesive with adjunct wound closure device for topical approximation of skin.
    - Nonresorbable gauze/sponge for external use.
    - Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
    - Hydrophilic wound dressing.
    - Occlusive wound dressing.
    - Hydrogel wound dressing and burn dressing.
    - Silicone sheeting.
    - Surgical apparel.
    - Organ bag.
    - Surgical camera and accessories.
    - Wound autofluorescence imaging device.
    - Introduction/drainage catheter and accessories.
    - Implantable clip.
    - Removable skin clip.
    - Contact cooling system for aesthetic use.
    - Cryosurgical unit and accessories.
    - Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
    - Surgical drape and drape accessories.
    - Irrigating wound retractor device.
    - Drape adhesive.
    - Electrosurgical cutting and coagulation device and accessories.
    - Low energy ultrasound wound cleaner.
    - Electrosurgical device for over-the-counter aesthetic use.
    - Microneedling device for aesthetic use.
    - Eye pad.
    - Nonabsorbable gauze for internal use.
    - Nonabsorbable expandable hemostatic sponge for temporary internal use.
    - Non-absorbable, hemostatic gauze for temporary internal use.
    - Hemostatic device for intraluminal gastrointestinal use.
    - Non-powdered surgeon's glove.
    - Surgeon's gloving cream.
    - Absorbable hemostatic agent and dressing.
    - Absorbable poly(glycolide/l-lactide) surgical suture.
    - Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
    - Stainless steel suture.
    - Polytetrafluoroethylene injectable.
    - Surgical lamp.
    - Focused ultrasound stimulator system for aesthetic use.
    - Ultraviolet lamp for dermatologic disorders.
    - Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
    - Skin marker.
    - Internal tissue marker.
    - Nonpowered, single patient, portable suction apparatus.
    - Non-Powered suction apparatus device intended for negative pressure wound therapy.
    - Extracorporeal shock wave device for treatment of chronic wounds.
    - Surgical microscope and accessories.
    - Surgical skin degreaser or adhesive tape solvent.
    - Surgical stapler.
    - Implantable staple.
    - Absorbable lung biopsy plug.
    - Removable skin staple.
    - Powered suction pump.
    - Negative pressure wound therapy device for reduction of wound complications.
    - Powered surgical instrument for improvement in the appearance of cellulite.

    - Manual surgical instrument for general use.
    - Manual percutaneous surgical set assembled in the abdomen.
    - Laser surgical instrument for use in general and plastic surgery and in dermatology.
    - Magnetic surgical instrument system.
    - Surgical instrument motors and accessories/attachments.
    - General laparoscopic power morcellation containment system.
    - Absorbable surgical gut suture.
    - Absorbable polydioxanone surgical suture.
    - Blood lancets.
    - Light based energy source device for topical application.
    - Suture retention device.
    - Manual operating table and accessories and manual operating chair and accessories.
    - Operating tables and accessories and operating chairs and accessories.
    - Nonabsorbable poly(ethylene terephthalate) surgical suture.
    - Nonabsorbable polypropylene surgical suture.
    - Nonabsorbable polyamide surgical suture.
    - Natural nonabsorbable silk surgical suture.
    - Nonabsorbable expanded polytetrafluoroethylene surgical suture.
    - Suction lipoplasty system.
    - Surgical smoke precipitator.

    - Air-handling apparatus for a surgical operating room.
    - Air-handling apparatus accessory.
    - Needle-type epilator.
    - Tweezer-type epilator.
    - Low level laser system for aesthetic use
    - Topical oxygen chamber for extremities.
    - Nonpneumatic tourniquet.
    - Pneumatic tourniquet.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 53 FR 23872, June 24, 1988, unless otherwise noted

Extracted from US.FDA