8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CARBOMEDICS VALVE TESTER
FDA 510(k)
FDA Class 1
·Cardiovascular
The Life Spine Subtalar Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code FZX·May 10, 2017
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 13, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 23, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020