BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MYLABGOLD

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828107709·GEN4 Direct Access

    EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEFENDO Y-OPSY IRRIGATOR

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

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    VERTEBRAL AUGMENTATION ACCESS KIT

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MQP·May 14, 2013

    ACTIVE® INHIBIN A ELISA, 4X96 WELLS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code NDR·June 1, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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