5,475 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·June 24, 2026
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
Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·June 10, 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