BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207014400·BRONCHOSCOPE-TUBE ID 8.5MM model Hemer, OD 9.5...

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114239·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·10610586023866·

    SILKRO

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

    NYCOCARD CRP CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    IOL MASTER

    FDA Adverse Event
    Other ·CARL ZEISS MEDITEC·Product code HJO·July 21, 2011

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·August 14, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

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