BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Aura 10 PET/CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021913·FPS 20mm Cannulated Metatarsal Reamer

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780498780·Integra® Miltex® Trousseau Tracheal Dilator, 5-...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215644·No-Profile Interbody, 39mm x 30mm x 14mm, 20 Deg

    3D Printed Interbody Systems

    FDA UDI
    Seaspine Orthopedics Corporation·10889981304072·2-Hole No-Profile Interbody, 39mm x 30mm x 14mm...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981309954·Trial Rasp, 39mm x 30mm x 14mm, 20 Deg

    PETITE BASIC SYSTEM 701 ELT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S & C -BRACKET ADHESIVES

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE PTE.LTD·Product code FRN·November 17, 2008

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 1, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    PRECISE SDS SELF EXPANDING

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code FGE·October 28, 2014

    UNKNOWN CARDIOVASCULAR ACCESS

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code DRE·October 28, 2014

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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