BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    ANESTHESIA BREATHING BAG, VARIOUS SIZES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838754·2.2MM PLATE LAG SCREW 16MM

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780119142·The standard forefoot screw is used in the Inte...

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788221160·Steerable IBD Trial 16x10x28, 6 deg

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113461·PS-C Insert, Size 1 x 16mm

    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELPH INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 9, 2012

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code MTA·August 24, 2010

    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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