19 results
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35ms
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Sources: EU EUDAMED, US FDA
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704204490·
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677569·Proximity 3-Level ACP, 60 mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584320·Apex Tibial Nail Ø 8.5 x 360mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529586782·Apex Femoral Nail GT Right Ø 8.5 x 360mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585884·Apex Femoral Nail GT Left Ø 8.5 x 360mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529581930·Apex Femoral Nail PF Right Ø 8.5 x 360mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587680·Apex Femoral Nail Retrograde Ø 8.5 x 360mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529580926·Apex Femoral Nail PF Left Ø 8.5 x 360mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677576·Proximity 3-Level X-Lordotic ACP, 60 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677590·Proximity 3-Level ACP, 60 mm
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
TULIP CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376677583·Proximity 3-Level X-Lordotic ACP, 60 mm
NOVOSYN VIOLET 2 (5) 4X70CM HR37STO (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·March 18, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 29, 2012
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·September 20, 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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015