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

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    QT Scanner 2000 Model A

    FDA 510(k)
    FDA Class 2 ·Radiology

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    priti®multidisc ZrO2

    FDA UDI
    Pritidenta GmbH·04251366905126·

    Tizian Blank 5.0

    FDA UDI
    Pritidenta GmbH·04251366906161·

    GARAVENTA SUPER-TRAC TRE-52

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Syntec Non-Sterile Steinmann Pins System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025

    ATLAS II VR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·November 3, 2014

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·August 23, 2011

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013

    MICROLET®

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025

    MICROLET®

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025

    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