BEUDAMED
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    Exactech® Novation® Crown Cup®

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOTRAX SERIES ULTRASONIC POCKET DOPPLER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COMPOSITE/COMPOMER REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    PLEURX LOCKABLE DRAINAGE LINE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    PLEURX

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·September 26, 2025

    PLEURX

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·June 2, 2025

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024