10 results
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26ms
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Sources: EU EUDAMED, US FDA
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