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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 6, 2024 | K233094 | Wellead® Latex Foley Catheter Well Lead Medical (Hainan) Co., Ltd., CN | MJC |
| Sep 29, 2004 | K040658 | BARDEX I.C. LATEX FOLEY CATHETER C.R. Bard, Inc. | MJC |
| Jun 10, 2004 | K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT Rochester Medical Corp. | MJC |
| Aug 30, 2000 | K000251 | SPECTRUM SILICONE FOLEY CATHETER Cook Urological, Inc. | MJC |
| Jul 7, 2000 | K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER Rochester Medical Corp. | MJC |
| Dec 10, 1999 | K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER C.R. Bard, Inc. | MJC |
| Feb 16, 1999 | K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER Bard Medical Div. | MJC |
| Nov 3, 1998 | K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 C.R. Bard, Inc. | MJC |
| Jan 13, 1998 | K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER Rochester Medical Corp. | MJC |
| Aug 18, 1994 | K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER C.R. Bard, Inc. | MJC |
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