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

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    FemaSeed Intratubal Insemination

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Audilab

    FDA UDI
    Sbo Hearing A/S·05714464033225·Aligo 5 FW 1.1.0

    BIOCRYL

    FDA UDI
    DEPUY MITEK, LLC·10886705010646·BIOCRYL INTERFERENCE SCREW Absorbable - TCP/PLA...

    Orfit

    FDA UDI
    Orfit Industries NV·05420028746479·

    Infant Half-Moon Clamp 13cm shanks curved

    FDA UDI
    Geister Medizintechnik GmbH·04057034063385·Infant Half-Moon Clamp 13cm shanks...

    Powered Inflatable Tube Massager - SLIM UP DRAIN

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    0.8% RESOLVE PANEL A FOR GEL

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KSZ·August 18, 2008

    PEDICAP

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HE...·Product code CCK·July 12, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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