BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    MAID MENTOR ASPIRATION/IRRIGATION DEVRO

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209118854·KIT, LOGGING FIRST AID - CUSTOM

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746047480·WIRE SS LOWER 016 X 022 FORM II 10/PK

    LAPARO-THORACO VIDEOSCOPE XLTF-VAW

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DISPOSABLE ADULT ANES. CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·November 30, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·September 27, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018