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

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    OrganProtex HTK Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 10, 2022

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 10, 2022

    GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ALARIS SYSTEM

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

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 20, 2008

    TI PANGEA(TM) LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code NKB·November 10, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 18, 2011

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 22, 2013

    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile

    FDA Enforcement
    Class II ·Ongoing·Spiggle & Theis Mt Gmbh·August 27, 2025

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 27, 2017

    TD TORQUE LINE CATHETER W/4 LUMENS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DYG·September 19, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 25, 2019

    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