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

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    AnyCheck IMT-100

    FDA 510(k)
    FDA Class 1 ·Dental

    MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VISENSIA, VISENSIA WITH ALERT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2020

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 24, 2024

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 14, 2015

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    TOTAL ASR ACET IMP SIZE 52

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 20, 2013

    ENDURANT ILIAC STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 22, 2011

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 20, 2015

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 30, 2024

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 7, 2024

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 21, 2024

    BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·April 19, 2021

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·April 19, 2021

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 28, 2022

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 21, 2024

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    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