7 results
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35ms
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Sources: EU EUDAMED, US FDA
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
FDA 510(k)
FDA Class 1
·Anesthesiology
RESUSCITATOR, PULMONARY, MANUAL
FDA 510(k)
FDA Class 2
·Anesthesiology
BLOM-SINGER SHOWER GUARD
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 28, 2015
PROXIMAL HUMERAL NAIL, CANNULATED, LEFT 8 X 150 M
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 9, 2010
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 18, 2014
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