8 results
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25ms
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Sources: EU EUDAMED, US FDA
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135370·
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BD·Product code FMF·May 28, 2014
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2010
PROSTIVA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code KNS·December 3, 2012
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