BEUDAMED
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    SUBCUTANEOUS INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AQUAMANTYS3 9.5 XL BIPOLAR SEALER

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

    TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPELLA CP

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·January 9, 2026

    EZ-PRO R4 AMBUL COT

    FDA Adverse Event
    Injury ·STRYKER CORP. MEDICAL DIV.·Product code FPO·December 7, 2010

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    LIFEVEST WCD 4000 SYSTEMQ

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021