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).

    - Rigidity analyzer.
    - Ataxiagraph.
    - Two-point discriminator.
    - Echoencephalograph.
    - Electroconductive media.
    - Cortical electrode.
    - Cutaneous electrode.
    - Depth electrode.
    - Nasopharyngeal electrode.
    - Needle electrode.
    - Electroencephalograph.
    - Electroencephalograph electrode/lead tester.
    - Electroencephalogram (EEG) signal spectrum analyzer.
    - Electroencephalograph test signal generator.
    - Neuropsychiatric interpretive electroencephalograph assessment aid.
    - Brain injury adjunctive interpretive electroencephalograph assessment aid.
    - Traumatic brain injury eye movement assessment aid.
    - Nystagmograph.
    - Computerized cognitive assessment aid.
    - Computerized cognitive assessment aid for concussion.
    - Neurological endoscope.
    - Esthesiometer.
    - Tuning fork.
    - Galvanic skin response measurement device.
    - Nerve conduction velocity measurement device.
    - Skin potential measurement device.
    - Evoked photon image capture device.
    - Powered direct-contact temperature measurement device.
    - Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
    - Alpha monitor.
    - Intracranial pressure monitoring device.

  - Cranial motion measurement device.
    - Percussor.
    - Pinwheel.
    - Ocular plethysmograph.
    - Rheoencephalograph.
    - Physiological signal amplifier.
    - Physiological signal conditioner.
    - Electroencephalogram (EEG) telemetry system.
    - Evoked response electrical stimulator.
    - Evoked response mechanical stimulator.
    - Evoked response photic stimulator.
    - Evoked response auditory stimulator.
    - Ultrasonic scanner calibration test block.
    - Near Infrared (NIR) Brain Hematoma Detector.
    - Tremor transducer.

Subparts C-D [Reserved]

    - Skull plate anvil.
    - Ventricular cannula.
    - Ventricular catheter.
    - Neurosurgical chair.
    - Scalp clip.
    - Aneurysm clip applier.
    - Clip forming/cutting instrument.
    - Clip removal instrument.
    - Clip rack.
    - Cryogenic surgical device.
    - Dowel cutting instrument.
    - Manual cranial drills, burrs, trephines, and their accessories
    - Powered compound cranial drills, burrs, trephines, and their accessories.
    - Powered simple cranial drills, burrs, trephines, and their accessories.
    - Cranial drill handpiece (brace).
    - Electric cranial drill motor.
    - Pneumatic cranial drill motor.
    - Radiofrequency lesion generator.
    - Neurosurgical headrests.
    - Neurosurgical head holder (skull clamp).
    - Cranioplasty material forming instrument.
    - Microsurgical instrument.
    - Nonpowered neurosurgical instrument.
    - Shunt system implantation instrument.
    - Stereotaxic instrument.
    - Leukotome.

  - Neurosurgical suture needle.
    - Neurosurgical paddie.
    - Radiofrequency lesion probe.
    - Skull punch.
    - Self-retaining retractor for neurosurgery.
    - Manual rongeur.
    - Powered rongeur.
    - Skullplate screwdriver.
    - Diagnostic neurosurgical microscope filter.

    - Methyl methacrylate for aneurysmorrhaphy.
    - Biofeedback device.
    - Conditioning tool for eating disorders.
    - Bite block.
    - Intravascular occluding catheter.
    - Carotid artery clamp.
    - Aneurysm clip.
    - Implanted malleable clip.
    - Aversive conditioning device.
    - Burr hole cover.
    - Nerve cuff.
    - Methyl methacrylate for cranioplasty.
    - Preformed alterable cranioplasty plate.
    - Preformed nonalterable cranioplasty plate.
    - Cranioplasty plate fastener.
    - Lesion temperature monitor.
    - Central nervous system fluid shunt and components.
    - Cerebrospinal fluid shunt system.
    - Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
    - Thermal system for insomnia.
    - Cranial electrotherapy stimulator.
    - Computerized behavioral therapy device for psychiatric disorders.
    - Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
    - Repetitive transcranial magnetic stimulation system.
    - Transcranial magnetic stimulator for headache.
    - External functional neuromuscular stimulator.
    - Implanted cerebellar stimulator.
    - Implanted diaphragmatic/phrenic nerve stimulator.
    - Implanted intracerebral/subcortical stimulator for pain relief.
    - Implanted spinal cord stimulator for bladder evacuation.
    - Implanted neuromuscular stimulator.
    - Implanted peripheral nerve stimulator for pain relief.
    - Implanted spinal cord stimulator for pain relief.
  - Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
    - Trunk and limb electrical stimulator to treat headache.
    - Transcutaneous electrical nerve stimulator for pain relief.
    - Transcutaneous electrical nerve stimulator to treat headache.
    - External vagal nerve stimulator for headache.
    - Thermal vestibular stimulator for headache.
    - Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
    - Vibratory counter-stimulation device.
    - Percutaneous nerve stimulator for substance use disorders.
    - Preformed craniosynostosis strip.
    - External upper limb tremor stimulator.
    - Dura substitute.
    - Electroconvulsive therapy device.
    - Neurovascular embolization device.
    - Temporary coil embolization assist device.
    - Skull tongs for traction.
    - Cranial orthosis.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

Extracted from US.FDA