BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    ProGrip Self-Gripping Polypropylene Mesh

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

    ambIT* KIDS PIB Pump-Blue

    FDA UDI
    Avanos Medical, Inc.·00193494001216·KIDS PIB Pump-Blue

    ambIT

    FDA UDI
    SUMMIT MEDICAL PRODUCTS, INC.·00857595005923·ambIT KIDS PIB Pump

    Ti-one 101

    FDA UDI
    HUNG CHUN BIO-S CO., LTD.·04719871590515·Abutment Ø6.5, 4.0 mm Abt. H The Ti-one 101 Den...

    REGENECARE WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIOBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIVACIT-E DM BEARING 28X44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 30, 2026

    BD SAFETYGLIDE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·December 3, 2023

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    UNKNOWN·Product code INI·November 3, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 18, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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