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

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    CERARESIN BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    BILLY BOY MALE LATEX CONDOM

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

    BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 22, 2024

    VORTEX

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC.·Product code LJT·August 14, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·October 2, 2015

    Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·August 21, 2019

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024