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).

    - Viscometer for cervical mucus.
    - Endocervical aspirator.
    - Endometrial aspirator.
    - Endometrial brush.
    - Endometrial suction curette and accessories.
    - Endometrial washer.
    - Uterotubal carbon dioxide insufflator and accessories.

 - Perineometer.
    - Amniotic fluid sampler (amniocentesis tray).
    - Fetal blood sampler.
    - Transabdominal amnioscope (fetoscope) and accessories.
    - Colposcope.
    - Culdoscope and accessories.
    - Transcervical endoscope (amnioscope) and accessories.
    - Hysteroscope and accessories.
    - Hysteroscopic insufflator.
    - Closed loop hysteroscopic insufflator with cutter-coagulator.
    - Gynecologic laparoscope and accessories.
    - Laparoscopic insufflator.

    - Obstetric data analyzer.
    - Obstetric-gynecologic ultrasonic imager.
    - Fetal cardiac monitor.
    - Fetal electroencephalographic monitor.
    - Fetal phonocardiographic monitor and accessories.
    - Fetal ultrasonic monitor and accessories.
    - Fetal scalp circular (spiral) electrode and applicator.
    - Fetal scalp clip electrode and applicator.
    - Intrauterine pressure monitor and accessories.
    - External uterine contraction monitor and accessories.
    - Home uterine activity monitor.
    - Perinatal monitoring system and accessories.
    - Computerized Labor Monitoring System.
    - Fetal stethoscope.
    - Obstetric ultrasonic transducer and accessories.
    - Telethermographic system.
    - Liquid crystal thermographic system.
    - Breast lesion documentation system.

    - Cervical drain.
    - Vaginal pessary.
    - Fallopian tube prosthesis.
    - Vaginal stent.

    - Gynecologic laparoscopic power morcellation containment system.
    - Endoscopic electrocautery and accessories.
    - Gynecologic electrocautery and accessories.
    - Bipolar endoscopic coagulator-cutter and accessories.
    - Unipolar endoscopic coagulator-cutter and accessories.
    - Expandable cervical dilator.
    - Hygroscopic Laminaria cervical dilator.
    - Vibratory cervical dilators.
    - Fetal vacuum extractor.
    - Fetal head elevator.
    - Obstetric forceps.
    - Obstetric fetal destructive instrument.
    - Obstetric-gynecologic general manual instrument.
    - Obstetric-gynecologic specialized manual instrument.
    - Gynecologic surgical laser.
    - Obstetric table and accessories.
    - Specialized surgical instrumentation for use with urogynecologic surgical mesh.

    - Metreurynter-balloon abortion system.
    - Vacuum abortion system.
    - Obstetric anesthesia set.
    - Nonpowered breast pump.
    - Powered breast pump.
    - Hemorrhoid prevention pressure wedge.
    - Pressure wedge for the reduction of cesarean delivery.
    - Abdominal decompression chamber.
    - Cervical cap.
    - Condom.
    - Condom with spermicidal lubricant.
    - Glans sheath.
    - Multiple-use female condom.
    - Single-use internal condom.
    - Contraceptive diaphragm and accessories.
    - Contraceptive intrauterine device (IUD) and introducer.
    - Software application for contraception.
    - Contraceptive tubal occlusion device (TOD) and introducer.
    - Perineal heater.
    - Menstrual cup.
    - Scented or scented deodorized menstrual pad.
    - Unscented menstrual pad.
    - Scented or scented deodorized menstrual tampon.
    - Unscented menstrual tampon.
    - Therapeutic vaginal douche apparatus.
    - Vaginal insufflator.
    - Powered vaginal muscle stimulator for therapeutic use.
    - Genital vibrator for therapeutic use.
    - Clitoral engorgement device.
    - Surgical mesh for transvaginal pelvic organ prolapse repair.

 - Assisted reproduction needles.
    - Assisted reproduction catheters.
    - Assisted reproduction accessories.
    - Assisted reproduction microtools.
    - Assisted reproduction micropipette fabrication instruments.
    - Assisted reproduction micromanipulators and microinjectors.
    - Assisted reproduction labware.
    - Intravaginal culture system.
    - Assisted reproduction water and water purification systems.
    - Reproductive media and supplements.
    - Assisted reproductive microscopes and microscope accessories.
    - Assisted Reproduction Embryo Image Assessment System.
    - Assisted reproduction laser system.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l , 371.
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

Extracted from US.FDA