13 results
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18ms
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Sources: EU EUDAMED, US FDA
AV Viewer
FDA 510(k)
FDA Class 2
·Radiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188513·Integra® Jarit® Hibbs Gouge, 9-1/2", Straight, ...
Monoblock Ball Stem Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215088293·
NA
FDA UDI
STRYKER CORPORATION·07613327056662·PEEK Multi-Function Handle
NA
FDA UDI
STRYKER CORPORATION·07613327056716·PEEK Monopolar Handle
NA
FDA UDI
STRYKER CORPORATION·07613327056686·PEEK Multi-Function Handle
NA
FDA UDI
STRYKER CORPORATION·07613327056679·PEEK Multi-Function Handle
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k)
FDA Class 1
·General Hospital
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
XPERT SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·September 15, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 23, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013