12 results
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25ms
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Sources: EU EUDAMED, US FDA
CARDI-CK EIA TEST KIT CK-MB ISOENZYME
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8430071·The DD cubeY® HL zirconium dioxide milling blan...
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
FDA 510(k)
FDA Class 2
·Hematology
Erchonia Zerona Z6 OTC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWER LOC
FDA Adverse Event
Malfunction
·BARD·Product code FPA·May 27, 2014
ORBIT GALAXY DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·November 21, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 23, 2010
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016
HELICAL BLADE EXTRACTOR
FDA Adverse Event
Malfunction
·Product code LXH·February 4, 2016
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 4, 2016
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