BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    PreXion3D Expedition

    FDA 510(k)
    FDA Class 2 ·Radiology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112861·CORNEAL TREPHINE BLADE6.0MM

    SPERMCARE Upper Layer - Gradient System

    FDA UDI
    INVITROCARE, INCORPORATED·00859268006183·SPERMCARE Upper Layer - Gradient System is a 45...

    TRIONOMER

    FDA 510(k)
    FDA Class 2 ·Dental

    GlidePath 7.5F Long-Term Dialysis Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 18, 2003

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·November 3, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·August 24, 2011

    PALINDROME 19/36 KIT W/ SLOT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·July 2, 2013

    BD PRECISIONGLIDE¿ NEEDLES

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·December 12, 2022

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·November 26, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·July 22, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 23, 2026

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 16, 2026

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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