11 results
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36ms
·
Sources: EU EUDAMED, US FDA
Aesculap AICON Container
FDA 510(k)
FDA Class 2
·General Hospital
HAWKEYE™ Vertebral Body Replacement (VBR)
FDA UDI
Choice Spine, LP·00840996101004·VBR,SPACER,12X14X41,0 DEG
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113850·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 S...
NBM-200MP
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·August 14, 2014
UNKNOWN
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code UNK·August 2, 2011
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 9, 2013
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 15, 2018
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·April 15, 2019
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019