BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    HEPAIRX VENTILATING AIR PURIFIER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEX-FIX

    FDA UDI
    Smith & Nephew, Inc.·23596010042402·HEX FIX BAR END CAP

    Drape Link Adapter

    FDA UDI
    Noras MRI products GmbH·04251269200571·

    E-SCAN MRI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARSTASIS ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS INC.·Product code DYB·November 15, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·ARSTASIS, INC.·Product code DYB·November 19, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·November 22, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·November 1, 2010

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·May 14, 2013

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL, INC.·Product code KNS·May 27, 2011

    CONQUEST PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·August 11, 2008

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021