BEUDAMED
    18 results · 19ms · Sources: EU EUDAMED, US FDA

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    CLIRANS E-SERIES DIALYZER

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

    Mini Twin

    FDA UDI
    Rmo, Inc.·00885797692207·STD EDG MINILP 022 W/O HK 5-5 20EA

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010024985·TENDON STRIPPER CLOSED

    EXTERNAL DISTRACTION

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036010836·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033510681·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361012764·PedFuse Remind LES, Quad-H, 5.0mm x 50mm

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795134240·3.5mm x 50mm, Threaded Peg, Ti

    INFINITY ETCO2 + RESPIRATORY MECHANICS POD

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINBN VANGUARD INT PS ANAT FM R 65MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·March 7, 2025

    ENDO ILS 21MM, CURVED

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 20, 2013

    ADU

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE FINLAND OY·Product code BSZ·February 3, 2011

    INSYNC II MARQUIS

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·March 10, 2008

    2710 CLEARTRACE LT

    FDA Adverse Event
    Other ·CONMED CORPORATION·Product code GXY·April 13, 2007

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 24, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024