Panels › Gastroenterology, Urology › Product code MJC · Class 2
Catheter, Urological (Antimicrobial) And Accessories
Regulation 876.5130
0510(k)s in 12 months (10 all time)
1recalls in 12 months (23 all time)
22recalls that name a 510(k)
Top companies in MJC
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 4 | 20 |
| Rochester Medical Corp. | 3 | 0 |
| Bard Medical Division | 0 | 2 |
| Bard Medical Div. | 1 | 0 |
| C.R. Bard, Inc., Urological Division | 0 | 1 |
| Cook Urological, Inc. | 1 | 0 |
| Well Lead Medical (Hainan) Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
*Bardex I.C. Complete Care Foley Catheter Tray
REF: 300316A
UDI codes: 00801741024344 10801741024341
*Bardex I.C. Complete Care Foley Catheter Tray and Urin Open, Classified |
MJC | K040658 K910318 +1 |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216 Open, Classified |
MJC | K040658 |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A Open, Classified |
MJC | K040658 |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A Open, Classified |
MJC | K040658 |
| Jun 18, 2024 | C.R. Bard Inc Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Gua Open, Classified |
MJC | K040658 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
MJC | K070582 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device Open, Classified |
MJC | K040658 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device Open, Classified |
MJC | K910318 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device Open, Classified |
MJC | K040658 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
MJC | K910318 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
MJC | K040658 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
MJC | K910318 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device Open, Classified |
MJC | K070582 |
| Apr 15, 2020 | C.R. Bard Inc SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the ur Terminated |
MJC | K040658 |
| Feb 6, 2019 | Bard Medical Division SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A3034 Terminated |
MJC | K910318 |
| Dec 6, 2018 | Bard Medical Division 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 Open, Classified |
MJC | K910318 |
| Jul 28, 2017 | C.R. Bard, Inc. Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, Terminated |
MJC | K033477 |
| Oct 5, 2016 | C.R. Bard, Inc. Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile
Product Usage:
The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal en Terminated |
MJC | K033477 |
| Dec 18, 2015 | C.R. Bard, Inc. BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, void Terminated |
MJC | K910318 |
| Dec 18, 2015 | C.R. Bard, Inc. BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical Terminated |
MJC | K910318 |
| Dec 18, 2015 | C.R. Bard, Inc. BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction an Terminated |
MJC | None listed |
| Nov 2, 2015 | C.R. Bard, Inc. Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units Terminated |
MJC | K033477 |
| Aug 21, 2003 | C.R. Bard, Inc., Urological Division Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is Terminated |
MJC | K984136 |
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