BEUDAMED
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    ACE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973868·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973783·

    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 17, 2019

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    INTERLOCKING DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·June 27, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554WWH

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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