BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 8, 2023

    RESTORELLE L

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

    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·November 4, 2008

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·July 14, 2011

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 2013

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 1, 2013

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 1, 2013

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 1, 2013

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 1, 2013

    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