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

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GUGLIELMI DETACHABLE (GDC)

FDA 510(k)
FDA Class 2 ·Neurology

3701 P37,1TO1,STANDARD,12",STKR

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828100816·3701 P37,1TO1,STANDARD,12",STKR

CONMED AER DEFENSE SMOKE EVACUATOR

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

PREGELLED DISPOSABLE ECG ELECTRODES

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 6, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

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