BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    FLARE,FILE, FILL

    FDA 510(k)
    FDA Class 1 ·Dental

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517673220·Brigade Implant, 12x34x36mm 8°

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981234·anteriors; shade B4; mould IM4

    Symmetry Surgical®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482086964·Symmetry® Tenaculum, Monopolar Handle w/Rotatio...

    GN OTOMETRICS INSERT EARPHONES

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

    Self-adhesive Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    EZ-PRO AMBULANCE COT OBS 11/99

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 27, 2013

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 5, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 1, 2011

    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.

    FDA Recall
    Terminated ·Circulatory Technology Inc·Product code DTN·June 3, 2009

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025