BEUDAMED
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    ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014

    MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIPAP PRO BI-LEVEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180507384·Pituitary, Straight Biting, Straight, 3MM, Lase...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180507391·Pituitary, Straight Biting, Straight, 5MM, Lase...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 20, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·October 9, 2018

    BENEVIEW MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY BIOMEDICAL ELECTRONICS CO.·Product code MHX·April 30, 2013

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 20, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 17, 2011

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 1, 2022

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 13, 2013

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014