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

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    INCUWARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074235202·INSTRUMENT 6971366 RASP

    Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTERPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018

    SPIROPERFECT

    FDA Adverse Event
    Malfunction ·MEDIKRO OY·Product code BZG·August 11, 2023

    7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 4, 2013

    SOFTCLIX® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 27, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 31, 2014

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019

    9680515-2008-00006

    FDA Adverse Event
    Other ·Product code HTX·June 16, 2008

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

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