8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE SALINE SOLUTION
FDA 510(k)
FDA Class 1
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126590·
STANDARD URINARY DRAINAGE BAG & LEG BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNIVERSAL PACK
FDA 510(k)
FDA Class 2
·Ophthalmic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 6, 2014
INTEGRA NPH LOW FLOW VALVE
FDA Adverse Event
Injury
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·November 28, 2012
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·September 30, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015