BEUDAMED
    13 results · 34ms · Sources: EU EUDAMED, US FDA

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    AQUA-SEAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 12, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 12, 2013

    ARCHITECT I2000SR ANALYZE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 12, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·November 12, 2013

    REVERE STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C2 Cryoballoon Ablation System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 15, 2014

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·January 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2012

    G2 FILTER SYSTEM - FEMORAL

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 31, 2013

    OT VERIO SYNC METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2015

    ACCOLADE DR EL MRI (Model L331)

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