BEUDAMED
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    INERTIA CONNEXX Modular Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLASSIC NMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALERE PBP2A TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCOLADE STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·November 4, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 21, 2011

    CCU BED WITH SCALE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 5, 2013

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025