BEUDAMED
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    Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517578594·CoRoent Ant TLIF Ti, 12x11x32mm 0°

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004390·Luna Opal R Mini .022 LU5 (-22°T 0°A)

    NA

    FDA UDI
    Synthes GmbH·10886982156327·1.3MM EXTENDED H-PLATE/RIGHT

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    Truliant

    FDA UDI
    Exactech, Inc.·10885862532022·TRULIANT POROUS TIB DRILL GUIDE, MEDIUM

    C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 11, 2013

    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