7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLSEN 756 ROCKER SWITCHPEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
PMT VAXIOM STEREOTACTIC SYS #FX001
FDA 510(k)
FDA Class 2
·Neurology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 14, 2010
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019