BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    Annalise Enterprise CTB Triage Trauma

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

    ST AIA-PACK CA 19-9

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·November 12, 2019

    ACCU-CHEK ® INSIGHT FLEX

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code FPA·October 4, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

    ION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 4, 2014

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011

    LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 12, 2013

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·December 3, 2013

    COPAN WASP/COLIBRI

    FDA Adverse Event
    Other ·COPAN WASP·Product code QQV·July 25, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    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