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

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    16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)

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

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515240728·Blair (Rollet) Ret, 4 shrp prongs, 6mm wide

    DERMA HOOD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOPATH** XCEL*

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·December 17, 2010

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·January 28, 2013

    RESTORE SENSOR MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 14, 2014

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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