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

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    Tyto Insights for Crackles Detection

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361029281·Ø14mm X 55mm Hybrid Fusion Screw, Gen II

    JOURNEY II BCS CONSTRAINED INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPAX CLIENT EMBRACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 15, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    ALARIS SYSTEM

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

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DRA·November 10, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·July 16, 2013

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 9, 2018

    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

    FDA Enforcement
    Class I ·Ongoing·Intersurgical Inc·July 23, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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