BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HTF-HEPES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 2, 2020

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 12, 2023

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 22, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 27, 2011

    GUNTHER TULIP VENA CAVA RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DTK·July 3, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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