9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY PRESERVATION UNICONDYLAR TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101918·All Poly 3 Peg Patella 26 mm x 8 mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199304·Patella Trial 26mm x 8mm
HARDYDISK, AMPICILLIN, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·March 26, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 5, 2011
LOW PROFILE EXTENSION
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 8, 2008
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016