BEUDAMED
    4,610 results · 18ms · 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 Classification: Class Ii × Status: Ongoing × Clear all

    Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    FDA Enforcement
    Class II ·Ongoing·TELEFLEX LLC·November 23, 2022

    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 3, 2025

    BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.

    FDA Enforcement
    Class II ·Ongoing·Bard Medical Division·February 13, 2019

    MOSAIQ Oncology Information System

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·June 17, 2026

    CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

    FDA Enforcement
    Class II ·Ongoing·INSPIREMD Inc·June 17, 2026