BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    EEG WITH VIDEO, MODEL EX-NW

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0100010·Caddie, Plates

    TiWAVE C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07320K0100110·Handle, Universal Slim with Depth Stops

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521010091D0·10 x 90 mm SI Implant with HA Coating

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0100010·Caddie, Common Plates and Screws

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0100010·Tamp, Modular Tip, InTess C

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 8, 2021

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 29, 2025

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100210·SNII Awl Tap, 5.50mm

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100210·Assembly, Caddie, Plates and Screws, Hinged

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100210·Caddie Lid, Rods, 5.5mm

    CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 17, 2025

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 11, 2025

    POLY-TAPE, 20 X 500MM

    FDA Adverse Event
    Injury ·XIROS·Product code JDR·December 6, 2011

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 11, 2011