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

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    Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD BBL™ Sabouraud Dextrose Agar (Deep Fill)

    FDA UDI
    BECTON, DICKINSON AND COMPANY·10382902211805·BD BBL™ Sabouraud Dextrose Agar

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197080385·CASTROVIEJO Micro Needle Holder 180mm,...

    GOMCO

    FDA UDI
    Allied Medical, LLC·00026072001783·ASPIRATOR, PORTABLE 1/15HP

    TriVerse Femoral Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215097820·

    Liver Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    CANDELA VBEAM PULSED DYE LASER SYSTEM

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

    BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·October 19, 2021

    AEYE-DS RETINA SCREENING

    FDA Adverse Event
    Injury ·AEYE HEALTH INC.·Product code PIB·January 22, 2025

    INRATIO

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·August 17, 2011

    CORAIL2 LAT COXA VARA SIZE 11

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·November 3, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

    BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·June 9, 2022

    BD BBL SABOURAUD DEXTROSE AGAR (DEEP FILL)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·March 15, 2021

    XP-CR Tibial Tray - Interlok 79 mm Item # 195276

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    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