9 results
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27ms
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Sources: EU EUDAMED, US FDA
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Uni-Flo
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005435·Uni-Flo™ Fenestrated Catheter – 10 inch (254mm)...
DeBakey-Derra Anastomosis Clamp 17cm
FDA UDI
Geister Medizintechnik GmbH·04057034056332·DeBakey-Derra Anastomosis Clamp 17cm
Bfix Orthopedic External Fixator Systems
FDA 510(k)
FDA Class 2
·Orthopedic
DSS STABILIZATION SYSTEM-RIGID
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·November 4, 2008
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
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