BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    C-MOR VISUALIZATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF

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

    BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 1, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2014

    3D KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·April 21, 2011

    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 22, 2015

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015