9 results · 24ms · Sources: EU EUDAMED, US FDA

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QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT

FDA 510(k)
FDA Class 2 ·Immunology

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209113828·

SEMPERFLO INFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

CorPath 200 System

FDA 510(k)
FDA Class 2 ·Cardiovascular

ETHILON NYLON SUTURE

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code GAR·June 6, 2014

HYDRATOME RX SPHINCTEROTOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·October 5, 2010

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 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

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

FDA Enforcement
Class II ·Terminated·STERILMED, INC.·December 16, 2015