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 |
|---|---|---|---|
| Nov 19, 1986 | K861699 | CATHETER VALVES KV 100 & KV 100EH Max Staubli , Ltd., CH | KOD |
| Nov 12, 1986 | K862098 | PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH Hall/Mccollum Laboratories, Inc. | KOD |
| Nov 7, 1986 | K863082 | COOK-VPI INTERMITTENT CATHETER Cook Urological, Inc. | KOD |
| Nov 4, 1986 | K863958 | TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY Cathaid, Inc. | KOD |
| Nov 4, 1986 | K863354 | BIO-GUARD AB COATED CATHETER Cook Urological, Inc. | KOD |
| Oct 31, 1986 | K863517 | FOLEY CATHETERS Instrumentation Industries, Inc. | KOD |
| Oct 31, 1986 | K863282 | CARE + PLUS CATHETER CARE TRAY Welmed Systems, Inc. | KOD |
| Oct 31, 1986 | K863281 | CARE + PLUS IRREGATION TRAY Welmed Systems, Inc. | KOD |
| Oct 3, 1986 | K863302 | MODIFIED FOLEY CATHETER Sheridan Catheter Corp. | KOD |
| Sep 9, 1986 | K862484 | HCI Y-CONNECTOR Hospital Concepts, Inc. | KOD |
| Aug 19, 1986 | K860325 | PRISTINE CULTURE CATHETER Hall/Mccollum Laboratories, Inc. | KOD |
| Aug 14, 1986 | K862124 | POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER Polymed Laboratories | KOD |
| Apr 23, 1986 | K861200 | UROTOPO CATHETER Houston Biomedical, Inc. | KOD |
| Apr 8, 1986 | K861181 | NORTA TEFLON COATED LATEX BALLOON CATHETERS Beiersdorf, Inc. | KOD |
| Apr 7, 1986 | K860265 | TELESCOPE PROTECTION TUBE R. J. Ltd., Ind. | KOD |
| Mar 25, 1986 | K860337 | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. Van-Tec, Inc. | KOD |
| Mar 11, 1986 | K860484 | CURITY & KENGUARD SILICONE COATED FOLEY CATHETER The Kendal Co. | KOD |
| Mar 11, 1986 | K855143 | ANGIOMED EXCHANGE DRAINAGE CATHETER SETS Angiomed U.S., Inc. | KOD |
| Mar 11, 1986 | K855076 | ANGIOMED URETER DIATION SETS Angiomed U.S., Inc. | KOD |
| Mar 4, 1986 | K854625 | UROTEC CLOSED IRRIGATIION SYRINGE Urotec Systems Corp. | KOD |
| Feb 24, 1986 | K855140 | ANGIOMED RENAL DILATION SET Angiomed U.S., Inc. | KOD |
| Jan 21, 1986 | K855077 | ANGIOMED HARZMANN DISCS Angiomed U.S., Inc. | KOD |
| Jan 8, 1986 | K854443 | O'NEIL URINARY CATHETER INTRODUCER Pennine Medical , Ltd. | KOD |
| Sep 20, 1985 | K852084 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP The Kendal Co. | KOD |
| Sep 12, 1985 | K853207 | PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE American Pharmaseal Div. Ahsc | KOD |
| Aug 23, 1985 | K853337 | TROCAR/CANNULA/SHEATH SET American Edwards Laboratories | KOD |
| Jul 29, 1985 | K851160 | VAN-TEC GUIDE WIRE W/HYDROMER COATING Van-Tec, Inc. | KOD |
| Jul 15, 1985 | K851857 | UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER Sheridan Catheter Corp. | KOD |
| Jul 2, 1985 | K851684 | UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER Urotec Systems Corp. | KOD |
| Apr 25, 1985 | K851180 | IRRIGATION TRAY Pace Pharmaceutical Services, Inc. | KOD |
| Apr 25, 1985 | K851179 | CATHETER CARE TRAY Pace Pharmaceutical Services, Inc. | KOD |
| Mar 25, 1985 | K850790 | DIAFLEX OCCLUSION BALLOON CATHETER American Edwards Laboratories | KOD |
| Mar 12, 1985 | K850335 | URETEROSCOPY CATHETER Inmed Corp. | KOD |
| Feb 28, 1985 | K850285 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY Premium Plastics, Inc. | KOD |
| Nov 21, 1984 | K842420 | NORTA SILICONIZED LATEX BALLOON CATH. Beiersdorf, Inc. | KOD |
| Sep 10, 1984 | K842866 | URETHRAL CATHETERIZATION TRAY Inmed Corp. | KOD |
| Sep 10, 1984 | K842228 | AIMED FOLEY CATHETER VARIOUS SIZES Tech-Cons Ltd., Intl. | KOD |
| Sep 4, 1984 | K842890 | PERCUFIX CATHETER CUFF Medi-Tech, Inc. | KOD |
| Aug 24, 1984 | K841769 | INTERMITTENT URETHRAL CATHETER TRAY Seamless Hospital Products Co. | KOD |
| Aug 8, 1984 | K841941 | VAN-TEC OCCLUSION BALLOON CATHETER Van-Tec, Inc. | KOD |
| Jul 19, 1984 | K841819 | CORPAK FOLEY CATH TRAY W/16FR. TEFLON Corpak Co. | KOD |
| Jul 19, 1984 | K841678 | STERILE, FOLEY CATHETERS W/PTFE COAT Abco Dealers, Inc. | KOD |
| Jul 12, 1984 | K841511 | HAEMATURIA CATHETERS Warne Surgical Products, Ltd. | KOD |
| Jul 9, 1984 | K841544 | AMER. PHARMASEAL SILICONIZED LATEX American Pharmaseal Div. Ahsc | KOD |
| Jun 7, 1984 | K841727 | UROLOGICAL CATHETER & ACCESSORIES Research Medical, Inc. | KOD |
| May 9, 1984 | K841485 | UROLOGICAL KIT W/STERILE, WATER-FILL Medline Industries, Inc. | KOD |
| Apr 17, 1984 | K840839 | MMG FOLEY CATHETER Medical Technologies of Georgia | KOD |
| Mar 7, 1984 | K832363 | FOLEY CATHETERIZATION TRAY-VARIOUS Inmed Corp. | KOD |
| Feb 4, 1984 | K834438 | TEMPERATURE SENSING FOLEY CATHETER C.R. Bard, Inc. | KOD |
| Jan 25, 1984 | K833719 | PREPACELL THIN NEEDLE ASPIRATION TRAY Applied Medical Devices, Inc. | KOD |
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