BEUDAMED
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    Spectral CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEAD LINED

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175002513·Enclosure, Preparation, 0.25" Lead, 230V

    InFill V2 Lateral PE

    FDA UDI
    PINNACLE SPINE GROUP, LLC·00814729021655·

    CERAMENT G

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Dental diode laser

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    SCULPTRA

    FDA Adverse Event
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.·Product code LMH·August 31, 2011

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·July 24, 2013

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017