BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    eRAD PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LZI Tramadol Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 12, 2023

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    UNK

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC·Product code JAA·November 9, 2008

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·September 9, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 22, 2013

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FPA·November 8, 2023

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014