8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THERMOSTATIC WATER MIXING VALVE TWV10
FDA 510(k)
FDA Class 2
·Cardiovascular
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
FDA 510(k)
FDA Class 1
·General Hospital
10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·November 29, 2016
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 5, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 7, 2012
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MRA·August 25, 2010
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