BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    HTS *1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GAYHEART CORNEAL EXCISION DEVICE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·February 5, 2014

    SYNTHES

    FDA Adverse Event
    Injury ·SYNTHES, INC·Product code HRS·October 26, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·August 30, 2010

    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