7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GORE-TEX SURGICAL MEMBRANE
FDA 510(k)
FDA Class 2
·Cardiovascular
INHANCE Shoulder System, Sterile Single Use Instrumentation
FDA 510(k)
FDA Class 2
·Orthopedic
PRISMAFLEX SYSTEM 7.10
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 14, 2012
COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2010
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019