7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S-41 &41S VIDEO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BOBCAT
FDA 510(k)
FDA Class 2
·Physical Medicine
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
FDA Recall
Terminated
·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·February 22, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·January 17, 2011
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NTE·August 1, 2014