8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DCI MODEL EP-2 CLINICAL STIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126859·
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
FDA 510(k)
FDA Class 1
·General Hospital
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·October 5, 2010
THREE-PC SYRINGES 2-30 ML, W. MOUNT.N
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FMF·March 26, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·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