8 results · 19ms · Sources: EU EUDAMED, 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