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

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036009526·

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·December 18, 2025

    MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PEDFUSE RESET DRIVER

    FDA Adverse Event
    Injury ·SPINEFRONTIER·Product code MNH·March 15, 2013

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES,INC·Product code MIH·February 28, 2011

    DUAL CHAMBER TEMP PACER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT·Product code DTE·February 20, 2008

    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

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020

    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