BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Merge PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYSTEM PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·AGILENTTECHNOLOGIES, INC·Product code MKJ·October 14, 2010

    MONARCH III IOL

    FDA Adverse Event
    ALCON·Product code KYB·November 30, 2012

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015