BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    USW NEEDLEKNIFE PAPILLOTOME

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

    HUIBREGTSE NEEDLE KNIFE PAPILLOTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022

    GSA GENITO SENSORY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Neurology

    CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

    FDA 510(k)
    FDA Class 2 ·Dental

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

    BD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2021

    ASPHERE M SPEC 12/14 40 +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 8, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2008

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 6, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    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