10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GENESIS TOUCH SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Patient Pad Breast Coil 3T
FDA UDI
Noras MRI products GmbH·04251269200243·
Patient Pad Breast Coil 3T
FDA UDI
Noras MRI products GmbH·04251269205293·
LO-BAK TRAX
FDA 510(k)
FDA Class 1
·Orthopedic
LIFTKAR PT
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
NEXGEN STEMMED PRECOAT TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·September 17, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 3, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025