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

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    Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994304957·IMPLANT 6240886 ANATOMIC 18X16X8MM

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216028211·ANATOMIC PEEK w/ Nano 18 x 16 x 8 x 4.6°

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000856748·IMPLANT 6240886 ANATOMIC 18X16X8MM

    ANATOMIC PEEK CERVICAL FUSION SYSTEM

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994360519·IMPLANT 4240886 ANATOMIC C 18X16X 8MM

    StimSite

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    WALKAIDE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOYER LIFT

    FDA Adverse Event
    Other ·APEX HEALTHCARE MFG, INC.·Product code FNG·November 10, 2008

    ON-Q, 400ML, 2-14ML/HR SELECT-A-FLOW PUMP

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·August 16, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·July 17, 2013

    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

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017