BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    AUTOJECT MINI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Release Laminoplasty Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AV Vascular

    FDA 510(k)
    FDA Class 2 ·Radiology

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

    D901 LILLIPUT OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·October 13, 2021

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·February 9, 2013

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 10, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2014

    CUSTOM PERFUSION PACK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 30, 2012

    LILLIPUT 1 START

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 17, 2023

    LILLIPUT 1 OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code DTZ·December 27, 2024

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·December 6, 2024

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·January 17, 2022

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·January 25, 2022

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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