BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    TERUMO SYRINGE WITH/WITHOUT NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400520340·Anterior Dome Osteotomy Guide, 52mm x 34mm

    ANS AXXESS PERCUTANEOUS LEAD

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 7, 2020

    2520274-2013-01910

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 11, 2013

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·March 2, 2011

    NOVASURE

    FDA Adverse Event
    Malfunction ·CYTYC SURGICALSERVICES, INC.·Product code MNB·May 12, 2008

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 17, 2021

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022