BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925019485·MASTOID RETRACTOR-SMALL

    Andwin Scientific

    FDA UDI
    Andwin Scientific·00187207000139·PAPKIT, 1 Slide, Scraper, Brush and Fixative Pump

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

    Cortera Spinal Fixation System

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311252749·Caddy, IMP, CC Cann, 8.5

    UNKNOWN_NEUWAVE

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·November 15, 2024

    UNKNOWN_NEUWAVE

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·November 15, 2024

    Dentis s-Clean s-Line Mini

    FDA 510(k)
    FDA Class 2 ·Dental

    EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RM52260045 DS10014522 BI MENTUM RK PE LINER 22 45

    FDA Adverse Event
    Injury ·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code MEH·January 23, 2025

    Salvin Dental Specialties

    FDA UDI
    SALVIN DENTAL SPECIALTIES, LLC·00841336120884·Wide Extraction Screw For Benex Pro Atraumatic ...

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 16, 2021

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 1, 2024

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 6, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·August 31, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 16, 2013

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 8, 2021

    2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HBE·June 29, 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