BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    BC-3600 Auto Hematology Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565990·CoRoent Ant TLIF PEEK, 14x13x34mm 8°

    UNIVERSAL RECONSTRUCTION RIBBON

    FDA UDI
    Biomet Orthopedics, LLC·00887868004315·

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828133449·GEN4 Direct Access

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·18100013401937·SINGLE INSTRUMENT

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·10840200301937·SINGLE INSTRUMENT

    DIGIVIEW 250

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO PM-8000 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROSENSOR KIT W/ SKULL BOLT

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·July 29, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014

    WALLFLEX? COLONIC

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - GALWAY·Product code MQR·June 3, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 29, 2011

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021