BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    LATEX SURGEONS GLOVE (POWDER FREE)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Diamond D

    FDA UDI
    Keystone Industries·H66810142831·Diamond D HIPA, 25 lb, LRP Pwd

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142130·Trial, TLIF, 32L OB CRV 7Deg, 13mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576632·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576670·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576649·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576687·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576663·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033576656·

    THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    9800

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

    IDENTITY XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    9900

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

    ARCHITECT TOTAL PSA

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code LTJ·August 28, 2014

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    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