BEUDAMED
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    ULTRACHEM URIC ACID AIDH, #65047

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214651·CUSTOM SURGICAL KIT VEIN ENDOVENOUS PACK

    MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Baby Gorilla/Gorilla Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATGUT PLAIN 4 (8) 25M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAL·January 14, 2014

    V40 COCR LFIT HEAD 40MM/-4

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·October 23, 2012

    XPER IM PHYSIOMONITORING SYSTEM

    FDA Adverse Event
    Death ·WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA INC.·Product code MWI·August 26, 2010

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012