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

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    SAPPHIRE PREMIERE

    FDA 510(k)
    FDA Class 2 ·Neurology

    36M - Kentucky Utilities

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588233031·Kentucky Utilities - 36 Metal

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM

    FEMORAL ACCESS VENOUS CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXPORT ASPIRATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·September 1, 2015

    RENAL - DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 13, 2010

    MONOCRYL PLUS SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·July 9, 2014

    MAVERICK OTW PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code LOX·April 6, 2006

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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