BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    COBAS-FP REAGENTS FOR VANCOMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H

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

    HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERNAL UNILOCK-SCR 3 SELF-TAP L16 5U

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·April 29, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·January 8, 2013

    MAVERICK BALLOON DILATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·November 17, 2010

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019