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This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
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Medical Devices Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. Supporting efficient clinical and business-related decisions
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This definition excludes all drugs and pharmaceuticals, while including the full range of medical devices: from as simple as a tongue depressor, to as complex as a robotic surgery device, and … The FDA defines a medical device as any product that is used in healthcare and does not achieve its purposes by chemical action or metabolization (section 201(h) of the FDCA). In today’s world health crisis and economic disarray, quality and precision of your medical products need to be a top priority. An official website of the United States government
Register today to attend the Devices Track during the Regulatory Education for Industry (REdI) Annual Conference. The first veterinary drug database to support commerce and dispensing
This definition excludes all drugs and pharmaceuticals, while including the full range of medical devices: from as simple as a tongue depressor, to as complex as a robotic surgery device, and everything in between.Devices are organized into a total of 16 comprehensive medical specialty “panels”, which are: Anesthesiology, Cardiovascular, Chemistry, Dental, Ear Nose and Throat, Gastroenterology and Urology, General and Plastic Surgery, General Hospital, Hematology, Immunology, Microbiology, Neurology, Obstetrical and Gynecological, Ophthalmic, Orthopedic, Pathology, Physical Medicine, Radiology, Toxicology.All 1,700 different types of medical devices are categorized according to their risk factor into 3 different classes.
For each type of device one of three regulatory classes is assigned, based on the risk categorization and consequently, the level of controls necessary to assure device safety and effectiveness.Determining the correct classification of your medical device is of crucial importance in all stages of the The FDA defines a medical device as any product that is used in healthcare and does not achieve its purposes by chemical action or metabolization (section 201(h) of the FDCA).
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