BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    Serranator PTA Serration Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WEGO-PGA Absorbable Surgical Suture With Needle

    FDA UDI
    Foosin Medical Supplies Inc., Ltd.·06941813601227·

    SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRACH VOX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURGAIRTOME TWO HANDPIECE

    FDA Adverse Event
    Other ·CONMED LINVATEC·Product code HBC·October 23, 2008

    COULTER® LH 750 SLIDEMAKER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKJ·August 16, 2011

    DUROM ACETABULAR COMPONENT 48/42 CODE H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·July 3, 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