7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ANA-CHECK
FDA 510(k)
FDA Class 2
·Immunology
MARINA MEDICAL SILICONE PESSARY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 11, 2012
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 10, 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