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

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    Eversense 365 Continuous Glucose Monitoring (CGM) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517071887·

    EXPEL APD DRAINAGE CATHETER SYSTEM

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

    PTM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 20, 2021

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE, INC.·Product code LZG·May 26, 2016

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·November 28, 2025

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEATHCARE CORPORATION·Product code KDJ·November 10, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·September 2, 2011

    ARTHROSCOPE

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·July 22, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    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