Panels › Gastroenterology, Urology › Product code EZC · Class 2
Catheter, Coude
Regulation 876.5130
0510(k)s in 12 months (7 all time)
1recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in EZC
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 4 | 10 |
| Teleflex Medical | 2 | 0 |
| C.R. Bard, Inc., Urological Division | 0 | 1 |
| Louisville Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bardex Lubricath Foley Catheter Tray
REF:
899914
899916
899918
UDI codes:
00801741024801 10801741024808
00801741024818 10801741024815
00801741024825 10801741 Open, Classified |
EZC | K910197 K910846 |
| Jul 3, 2025 | C.R. Bard Inc REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray Open, Classified |
EZC | K910846 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray Open, Classified |
EZC | K910846 |
| Dec 13, 2017 | C.R. Bard, Inc. Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522) Terminated |
EZC | K910195 |
| Sep 7, 2012 | C.R. Bard, Inc., Urological Division Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use.
Used to catheterize patients. The finished trays ar Terminated |
EZC | None listed |
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