Medical Devices & Implants
The Food & Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices as required by Congress in the Food, Drug, and Cosmetic Act (Act). The Act defines a medical device as "an instrument, apparatus, . . . machine, implant, . . . or other similar article that is intended for use in the . . . treatment or prevention of disease." Medical devices can be anything from a breast implant to a pacemaker to a hearing aid. The term is broad and includes items that the public may not consider to be medical devices, such a condoms, the Lasik procedure, and tampons.
Click below to learn more about some specific medical devices and implants and some of their more serious adverse side effects.
- Abbott Axsym Beta-HCG Pregnancy Test
- Aneurysm Graft
- BioGlue
- Bladder Control and Urinary Incontinence Devices
- Bone Screws
- Breast Implants
- Bronchoscopes
- Catheters
- Clinipad Antiseptic Sterile Products
- Cochlear Implants
- Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System
- CT Scan
- Dental Amalgams
- Dental Sealants
- Disetronic Insulin Infusion Pumps
- Extended Wear Contact Lenses
- FD & C Blue No. 1 (Blue 1)
- Heart Devices
- Hip Replacement
- Knee Replacement
- Lap-Band
- Medtronic Model 8870 Software Application Cards
- Medtronic Paradigm Quick-Set Plus Insulin Infusion Sets
- Nellcor CapnoProbe SLS-1 Sublingual Sensors
- NeuroCybernetic Prosthesis System (NCP)
- Perfix Hernia Plug
- ProbeTec ET Instrument
- Respironics, Inc. ComfortGel Nasal Masks
- Rife Frequency Generators
- Shiley TracheoSoft XLT Extended Length Tracheostomy Tubes
- Surestep Blood Glucose Meter
- VIDAS Chlamydia Assay
-- Article Courtesy of InjuryBoard.com
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