BEUDAMED
    11 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.

    KNIFE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209135134·

    DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT

    FDA 510(k)
    FDA Class 1 ·Hematology

    SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PINN SECTOR W/GRIPTION 56MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 15, 2013

    SUNBEAM

    FDA Adverse Event
    Injury ·SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS·Product code IRT·May 27, 2014

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·December 3, 2012

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 22, 2013

    ASPHERE M SPEC 12/14 40 -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 22, 2013

    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