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Products and Medical Procedures

Products and Medical Procedures

The FDA regulates medical devices sold in the United States to assure their safety and effectiveness.

Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. Our Medical Device Product Classification database lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the classification assigned to each type.

Depending on the device classification, along with other factors, federal regulations (such as the Code of Federal Regulations, Title 21) define requirements that must be fulfilled for CDRH to approve or clear devices sold in the United States.

 


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Medical Device Approvals and Clearances

Recently-Approved Devices

Learn about the latest device approvals, including what medical uses the device is cleared or approved for, when it can be used, and when it should not be used.

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Medical Devices by Purpose

Cosmetic Devices

Devices used to improve appearance, such as dermal fillers (soft tissue fillers).

General Hospital Devices and Supplies

Devices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical device connectors, medical device data systems (MDDS), and sterilization systems (liquid chemical, ethylene oxide).

Home Health and Consumer Devices

Devices that consumers use themselves, such as bed rails, breast pumps, contact lenses, hearing aids, sharps (needles and syringes), electronic muscle stimulators, and artificial pancreas device systems.

Implants and Prosthetics

Devices or tissues that are placed inside or on the surface of the body, including breast implants, cochlear implants, mesh implants, phakic intraocular lenses, and cerebral spinal fluid (CSF) shunt systems.

In Vitro Diagnostics (Tests and Testing)

Tests done on samples such as blood or tissue that have been taken from the human body, such as blood glucose monitoring devices, direct-to-consumer tests, drugs of abuse tests, home use tests, laboratory developed tests, nucleic acid based tests, and warfarin INR test meters.

Obesity Treatment Devices

Devices used by health care professionals to treat obesity, such as gastric bands, electrical stimulation systems, gastric balloon systems, and gastric emptying systems.

Surgery Devices

Devices used in surgical procedures, such as laparoscopic power morcellators, LASIK, and computer-assisted or robotic surgical systems.

Medical Devices by Specialty

Pediatric Medical Devices

Devices used to diagnose or treat diseases and conditions in newborns, infants, children, and adolescents through age 21.

Cardiovascular Devices

Devices used to diagnose and treat heart disease and related health problems, such as automated external defibrillators (AEDs) and heater-cooler devices.

Neurological Devices

Devices used to diagnose, prevent, and treat neurological disorders and conditions, such as devices for assessing head injury.

Dental Devices

Devices used to maintain dental health and treat dental problems, such as denture adhesives, dental amalgam, dental unit waterlines, and multiple-use dental dispenser devices (dental syringes).