8 results · 26ms · Sources: EU EUDAMED, US FDA

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IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

OXIMETRIX SHAW HEMOSTATIC SURG. SYS.

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

A1AT Genotyping Test

FDA 510(k)
FDA Class 2 ·Immunology

ION¿

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 21, 2013

SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL

FDA Adverse Event
Other ·GLAXOSMITHKLINE·Product code KOL·January 17, 2011

TAPER SLEEVE ADAPTER 12/14 +2

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 31, 2014

REMINGTON MEDICAL DISPOSABLE PACING CABLE

FDA Adverse Event
Malfunction ·REMINGTON MEDICAL·Product code DSA·September 13, 2002

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