9 results
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19ms
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Sources: EU EUDAMED, US FDA
NATELSON TUBES, HEPARIN AND PLAIN
FDA 510(k)
FDA Class 1
·Hematology
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403151781·Snowden-Pencer Plastics RETRACTOR TEBBETTS FIBE...
INFUSION SET W/ INJECTION SITE, 23D-W
FDA 510(k)
FDA Class 2
·General Hospital
BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001
FDA 510(k)
FDA Class 2
·Cardiovascular
UNK V. MUELLER
FDA Adverse Event
Injury
·CAREFUSION·Product code FDG·March 26, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·October 5, 2010
HYPODERMIC NEEDLE PRO INSULIN SYRINGE W/EDGE SAFETY DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INC·Product code FMF·February 10, 2014
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD·Product code FRN·November 14, 2012
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