11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLUTARALDEHYDE MONITORS
FDA 510(k)
FDA Class 2
·General Hospital
VLS 5300 300W XENON LIGHT SOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVI MODEL 285CI INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
EGIA 60 ARTICULATING VAS/MED SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY U.S. SUR·Product code GDW·June 25, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·December 9, 2010
ADVANCED BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 14, 2012
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012