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

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    DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    Rutner

    FDA UDI
    COOK INCORPORATED·00827002145474·Rutner Balloon Dilation Helical Stone Extractor

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142150·Trial, TLIF, 32L OB CRV 7Deg, 15mm

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361013525·Quad Thread Cannulated Ø6x55

    3D LINE STEROTACTIC HARDWARE ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAVITY VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GCJ·March 27, 2019

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013

    ACCU-CHEK ® MULTICLIX LANCETS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 10, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 12, 2008

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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