BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    Respiree Cardio-Respiratory Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LCP

    FDA UDI
    Synthes GmbH·10886982158130·3.5MM LCP PLATE 20 HOLES 267MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776412777·J-Hook Electrode 5mm x 36mm with Rear Mounted R...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180138209·5 MM DIA., 36CM, INSULATED MONOPOLAR J-HOOK, CO...

    1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    RENEGADE STC 18 MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPD SOLUTION TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 25, 2011

    TRUETRACK

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code CGA·August 5, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 21, 2022

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 21, 2022

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

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

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

    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