BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

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    TABLE, X-RAY, RFX CLASSICAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Response 5.5 Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 21, 2014

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·September 26, 2012

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 15, 2010

    BIPLATE SCHAEDLER/SCHAED KV 5% SB 20

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·June 25, 2021

    BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·August 2, 2021

    BIPLATE SCHAEDLER/SCHAED KV 5% SB 20

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·July 1, 2021

    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·October 3, 2012

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025