BEUDAMED
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    HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209104093·

    Sysmex Automated Blood Coagulation Analyzer CS-2100i

    FDA 510(k)
    FDA Class 2 ·Hematology

    VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100

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

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·March 26, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 29, 2012

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·September 23, 2010

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024