BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    Unity Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-Portal Portable Assessment System - Nystagmograph (I-PAS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM

    FDA 510(k)
    FDA Class 2 ·Dental

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 1, 2025

    OPTICROSS HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026

    ELLIPSE VR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 15, 2014

    CAPD DISCONNECT Y SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 24, 2011

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·June 17, 2013

    OPTICROSS? HD

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020