BEUDAMED
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    Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEALIX TRANSTEND ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705008063·HEALIX TRANSTEND Ti Anchor with ORTHOCORD Titan...

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78822226000201·EXP SL Weld Tube MBT 022/UL6-14T 0A 10D HK

    AYCAN MOBILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 12, 2013

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025