Panels › Gastroenterology, Urology › Product code KOD · Class 2
Catheter, Urological
Regulation 876.5130
1510(k)s in 12 months (238 all time)
1recalls in 12 months (108 all time)
80recalls that name a 510(k)
Top companies in KOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Nurse Assist, Inc | 0 | 34 |
| C.R. Bard, Inc. | 10 | 12 |
| COVIDIEN LLC | 0 | 17 |
| Teleflex Medical | 0 | 17 |
| Rochester Medical Corp. | 2 | 14 |
| Convatec Limited | 3 | 7 |
| Abco Dealers, Inc. | 9 | 0 |
| Van-Tec, Inc. | 8 | 0 |
| Boston Scientific Corp | 5 | 2 |
| The Kendal Co. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 28, 1983 | K833432 | CATHETER INSERTION KIT Clinipad Corp. | KOD |
| Dec 27, 1983 | K833790 | CURITY 100% SILICONE COUDE' CATHETER The Kendal Co. | KOD |
| Sep 19, 1983 | K832389 | CATHETER CARE TRAY Inmed Corp. | KOD |
| Sep 12, 1983 | K832692 | CURITY CATHETER STRAP The Kendal Co. | KOD |
| Sep 12, 1983 | K831743 | STERILE FOLEY CATHETERS & UROLOGICAL Electromedics, Inc. | KOD |
| Aug 10, 1983 | K831567 | FOLEY-TEMP Mallinckrodt Critical Care | KOD |
| Aug 8, 1983 | K832165 | IMPROVED SILICATH SILICONE ELASTOMER Travenol Laboratories, S.A. | KOD |
| Jun 17, 1983 | K831244 | URETERAL STONE EXTRACTOR CATHETER American Edwards Laboratories | KOD |
| May 27, 1983 | K831369 | LATEX URINARY CATHETERS Wayne Surgical Products | KOD |
| Mar 17, 1983 | K830359 | STERILE CATHERIZATION PROCEDURE TRAYS Welcon, Inc. | KOD |
| Mar 9, 1983 | K830444 | STERILE, ALL PURPOSE URETHRAL CATHETER Abco Dealers, Inc. | KOD |
| Jan 9, 1983 | K823818 | CATHETER HOLDER Danek Medical, Inc. | KOD |
| Sep 24, 1982 | K821818 | RETRIEVAL BALLOONS American Endoscopy, Inc. | KOD |
| Jul 21, 1982 | K821970 | DYNACOR URETHRAL CATHETER TRAY Medline Industries, Inc. | KOD |
| Jun 24, 1982 | K821745 | BARDEX ALL SILICONE PEDIATRIC CATHETER C.R. Bard, Inc. | KOD |
| Jun 22, 1982 | K821272 | BN-74 COATED BARDEX ALL SILICONE CATH C.R. Bard, Inc. | KOD |
| May 13, 1982 | K820987 | FOLEY INSERTION TRAYS W/OVERWRAY Inmed Corp. | KOD |
| May 11, 1982 | K820838 | CURITY ECONOMY I CYSTOSCOPY The Kendal Co. | KOD |
| Apr 26, 1982 | K820868 | URETERAL CATHETER CONNECTOR Van-Tec, Inc. | KOD |
| Apr 26, 1982 | K820866 | URETERAL CATHETER CONNECTING TUBE Van-Tec, Inc. | KOD |
| Mar 26, 1982 | K820239 | RETRIEVAL FORCEPS American Endoscopy, Inc. | KOD |
| Mar 25, 1982 | K820637 | CATH-HOLD Womco Products | KOD |
| Mar 23, 1982 | K820419 | AM. PH. STERILE SINGLE-USE URETHRAL CATH American Pharmaseal Div. Ahsc | KOD |
| Mar 1, 1982 | K820313 | VPI-FAIR URETHRAL STENT Vance Products, Inc. | KOD |
| Mar 1, 1982 | K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER Vance Products, Inc. | KOD |
| Nov 17, 1981 | K812887 | ROBINSON CATHETERS NON-STERILE Abco Dealers, Inc. | KOD |
| Nov 10, 1981 | K811924 | PRE-FILLED SYRINGE & CYSTOFLO URINARY BG Travenol Laboratories, S.A. | KOD |
| Oct 13, 1981 | K812281 | TOUCHLESS HOME-CATH Diamed Division Ill. Tool Works, Inc. | KOD |
| Jul 20, 1981 | K811277 | CATH-DAP Northwest Alabama Urological Assoc. | KOD |
| Apr 23, 1981 | K810690 | CURITY 100% SILICONE SAFETY INDICATOR The Kendal Co. | KOD |
| Apr 7, 1981 | K810249 | TRAY, CATHERIZATION, URETHRAL Megaplast, Inc. | KOD |
| Mar 31, 1981 | K810630 | SILICONE ELASTOMER COATED LATEX FOLEY G.D. Searle and Co. | KOD |
| Mar 20, 1981 | K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET Vance Products, Inc. | KOD |
| Mar 20, 1981 | K810367 | KISH URETHRAL ILLUMINATED CATHETER SET Vance Products, Inc. | KOD |
| Feb 25, 1981 | K810281 | UROLOGICAL CATHETERS Latex Ind., Inc. | KOD |
| Feb 9, 1981 | K810216 | ARGYLE ROB-NELS Sherwood Medical Co. | KOD |
| Jan 9, 1981 | K803259 | CLOSED SYSTEM URETHRAL CATHETERIZ. SET Medical Devices, Inc. | KOD |
| Jan 7, 1981 | K803062 | CATH-SECURE Melissa C. Johnson | KOD |
| Jan 2, 1981 | K802878 | K-KATH URETHRAL CATHETER INTRODUCER B&K Medical | KOD |
| Dec 22, 1980 | K803080 | ALL PUPOSE URETHRAL CATHETER American Hospital Supply Corp. | KOD |
| Dec 22, 1980 | K803079 | FOLEY CATHETER American Hospital Supply Corp. | KOD |
| Dec 16, 1980 | K802875 | ARGYLE HEMATURIA BALLOON CATHETER Sherwood Medical Co. | KOD |
| Nov 12, 1980 | K802665 | TOUCHLESS CLEAN-CATH Diamed Division Ill. Tool Works, Inc. | KOD |
| Oct 31, 1980 | K802516 | FOLEY CATHETER Abco Dealers, Inc. | KOD |
| Oct 21, 1980 | K801820 | FOLEY CATHETERIZATION TRAY Abco Dealers, Inc. | KOD |
| Oct 21, 1980 | K801787 | URINARY CATHETER CARE TRAYS #3700&3710 The Healthcare Group Laboratories, Inc. | KOD |
| Oct 21, 1980 | K801785 | URETHRAL CATHETERIZATION TRAYS The Healthcare Group Laboratories, Inc. | KOD |
| Sep 30, 1980 | K801786 | URINE COLLECTION CONTAINERS, #3600 &3610 The Healthcare Group Laboratories, Inc. | KOD |
| Sep 16, 1980 | K802083 | CATHETER INSERTION TRAY Walpak Co. | KOD |
| Aug 20, 1980 | K801415 | LATEX FOLEY CATHETER (HYDROMER COATED) G.D. Searle and Co. | KOD |
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