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

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    Nuance Audio Hearing Aid Software

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517198679·MaXcess 4 Blade, 150mm Electrode Ctr

    Syntec-Taichung Non-sterile Bone Plate and Screw Implants

    FDA UDI
    SYNTEC SCIENTIFIC CORPORATION·04719864684993·Straight Mini Plate 2.0 x 5Holes x L29mm

    Flex

    FDA UDI
    Diversified Products, Inc.·00842894172872·

    TAPERLOC COMPLETE RASP/PROVISIONAL

    FDA UDI
    Biomet Orthopedics, LLC·00880304632479·

    RGX 3 PEG SER A PATELLA

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HRY·July 1, 2019

    AMADEUS II EPIKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CO2 monitoring line with and without in-line filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 15, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    IFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 21, 2008

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012