BEUDAMED
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    BIOPLEX 2200 MMRV IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989026825·ARCH P/F EDG SQ LWR 016 X 016 PK10

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127635·AK3 Congruent Insert Trial Size 6, 16mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450279410·

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962108956·GROOVED DIRECTOR PROBE POINT, 7"

    INDUO BLOOD GLUCOSE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    TITAN TOUCH

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FHW·March 10, 2022

    UNIFY CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    2520274-2013-02341

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·May 3, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code GZB·April 28, 2011

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018