8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERVICAL COLLARS & HEAD HALTERS
FDA 510(k)
FDA Class 1
·Physical Medicine
MASK ELBOW
FDA UDI
King Systems Corporation·00612649216263·PORTED ELBOW w/ PURPLE CAP
Medtronic Confida Brecker Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMUNALYSIS COCAINE ELISA FOR HAIR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CATGUT CHROMIC 2 (6) 50M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAL·March 18, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 27, 2012
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code ODG·September 21, 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