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

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    Medline UNITE® REFLEX® Hybrid Nitinol Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828138789·GEN4 DIGITAL

    Single-use Balloon Dilatation Catheter

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

    Calibra Abutment Resin Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2025

    ANTIMICROBIAL PICC KIT 2-LUMEN: 5.5 FR X

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code LJS·August 24, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 11, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 23, 2013

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·May 7, 2025

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 10, 2014

    PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GDW·December 7, 2018

    PROXIMATE PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GDW·December 7, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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