BEUDAMED
    7 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.

    GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OXLIFE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VACPAC PORTABLE ASPIRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ECHELON* 60 ENDOPATH** STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 3, 2010

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FSA·July 3, 2014

    ADEL OBS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·December 6, 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