65 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VASCULAR PROBE, VASCULAR PROBE ES
FDA 510(k)
FDA Class 2
·Cardiovascular
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
GYRUS ACMI HALO PKS CUTTING FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RELIANCE SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 12, 2015
CAIMAN DISP. INSTR. ARTICULAT. D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·November 11, 2014
CAIMAN DISP. INSTR. ARTICULAR D-12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·May 6, 2014
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GEI·March 21, 2014
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014
CAIMAN DISP.INSTR.NON ARTICUL. D: 5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·June 17, 2015
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360 MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·June 17, 2015
CAIMAN DISP. INSTR. ARTICULAT. D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·November 11, 2014
CAIMAN DISP. INSTR. ARTICULAT. D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·November 11, 2014
CAIMAN DISP, INSTR. ARTICULAR. D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·March 12, 2014
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code GEI·November 1, 2015
CAIMAN DISP. INSTR. NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·March 12, 2014
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015
CAIMAN DISP.INSTR.NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·March 12, 2014
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 30, 2014