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

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    Pre-Formed Extra Support Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTEGRA(TM) CUSA NXT(TM) BONE TIPS

    FDA 510(k)
    FDA Unclassified ·Unknown

    CRIT-LINE MONITOR III TQA (CLM TQA)

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    GDC-10 ULTRASOFT COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code HCG·October 24, 2008

    ARTICUL/EZE BALL 28 +1.5 GR

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·August 10, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code OAE·September 17, 2025

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Death ·ABBOTT MEDICAL·Product code OAE·September 17, 2025

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    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