9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SR1 DHEA-S ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ARCOMXL POLYETHYLENE LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
PRELUDE PLASTIC JACKETED GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
OXF UNI TIB TRAY SZ B LM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·June 21, 2017
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 9, 2010
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·July 17, 2014
ORTHOLOCK EX-PIN 3X110
FDA Adverse Event
Malfunction
·STRYKER NAVIGATION·Product code HAW·December 27, 2012
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021