10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANALYST PHYSICIAN'S OFFICE PROFILER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130627·
RECLAIMTM
FDA UDI
DEPUY (IRELAND)·10603295554455·RECLAIMTM MONOBLOC REVISION FEMORAL STEM STANDA...
RECLAIM
FDA UDI
DEPUY (IRELAND)·10603295533603·RECLAIM MONOBLOC REVISION FEMORAL STEM EXTRA LO...
CAMPYLOBACTER THIOGLYCOLLATE MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
MODEL M410D HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 6, 2014
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·November 29, 2012
WHITESTAR SIGNATURE
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code HQC·September 4, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015