9 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Unger Quad Injector
FDA 510(k)
FDA Unclassified
·Unknown
VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
JOULE CLEARSENSE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 6, 2019
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2019
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·September 15, 2008
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014