7 results
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17ms
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Sources: EU EUDAMED, US FDA
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BLOOD CULTURE HOLDER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 7, 2012
DXTEND SCREW LOCK D4.5X24MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code HSD·August 27, 2010
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