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

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    BIB Stent Placement Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DE48-PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIDECO LILIPUT ECMO M PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 20, 2012

    COVEREDGE 32

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 18, 2024

    LEKTRAFUSE HF GENERATOR BIPOLAR

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·October 6, 2014

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·August 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019