7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LPA-2 REMOTE ALARM
FDA 510(k)
FDA Class 2
·Anesthesiology
CR-39 TYPE RESIN
FDA 510(k)
FDA Class 1
·Ophthalmic
BD ULTRA-FINE 31G X 8MM INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BD·Product code FMI·May 28, 2014
CONSULTA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·October 5, 2010
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code NEK·November 27, 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