BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    SPLINTS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LED HEADLIGHT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·May 25, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 14, 2012

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2010

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    TFNA FEM NAIL Ø11 R 130° L360 TIMO15

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·February 23, 2023

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017