8 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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