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

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    SENTINEL IRON LIQUID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Harvard Ionoglas Fill A2

    FDA UDI
    Harvard Dental International GmbH·EHAR70511151·Classical glass ionomer restorative cement

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58211150·CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192459·Apex Revision Knee Reamer – ZIMMER LONG FLUTES,...

    Medstone

    FDA UDI
    Stille AB·07332339222284·Fistula Board sparepart without pad that slides...

    ULTRA CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 10, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 12, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 21, 2008

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 10, 2010

    CELL-DYN RUBY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 31, 2019

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018