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 |
|---|---|---|---|
| Aug 6, 1992 | K921253 | INSTRUMENT IRRIGATION PUMP Psi Medical Products, Inc. | KOD |
| Jan 31, 1992 | K914933 | HEART PACK III Westmark Hospital Supplies | KOD |
| Jan 30, 1992 | K912851 | NAUDE URETHRAL STENT Cook Urological, Inc. | KOD |
| Apr 25, 1991 | K911242 | KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health | KOD |
| Dec 14, 1990 | K900509 | NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH Medical Latex Corp., MY | KOD |
| Nov 21, 1990 | K904734 | PHARMASEAL DISPOSABLE ABDOMINAL TROCAR Baxter Healthcare Corp | KOD |
| Nov 5, 1990 | K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER Unoplast A/S, DK | KOD |
| Aug 6, 1990 | K896750 | LOFRIC(R), LOFRIC(R) CATH-KIT Astra Meditec AB, SE | KOD |
| Jun 27, 1990 | K901738 | SELFCATH Vitaid, Ltd. | KOD |
| Apr 17, 1990 | K900229 | BARD CONFORMACATH FOLEY CATHETER C.R. Bard, Inc. | KOD |
| Mar 15, 1990 | K900022 | BJ STAR ALL SILICONE FOLEY BALLOON CATHETER B.J. Star, Inc. | KOD |
| Feb 26, 1990 | K896726 | 4 SURE EXTERNAL MALE CATHETER The Boston & Pacific Co., Inc. | KOD |
| Feb 16, 1990 | K896784 | DISPOSABLE URODYNAMIC CATHETER SET Life-Tech Intl., Inc. | KOD |
| Feb 16, 1990 | K896725 | 4 SURE UROLOGICAL CATHETER The Boston & Pacific Co., Inc. | KOD |
| Feb 12, 1990 | K896053 | ALL SILICONE FOLEY CATHETER Rochester Medical Corp. | KOD |
| Feb 9, 1990 | K895548 | CONVEEN INTERMITTENT CATHETERS Coloplast A/S | KOD |
| Jan 22, 1990 | K896385 | URETERAL ACCESS SET Applied Urology, Inc. | KOD |
| Jan 18, 1990 | K896213 | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET Westmark, Sterile Packing Systems, Inc. (Sps) | KOD |
| Jan 18, 1990 | K896211 | CYSTOSCOPY/IRRIGATION SET Westmark, Sterile Packing Systems, Inc. (Sps) | KOD |
| Jan 18, 1990 | K896208 | CYSTO PUMP DRAINAGE BAG Westmark, Sterile Packing Systems, Inc. (Sps) | KOD |
| Sep 12, 1989 | K890400 | MODIFIED URINARY CATHETER INTRODUCER (UCI) Go Medical Industries Pty. , Ltd., AU | KOD |
| Sep 7, 1989 | K893390 | MODIFIED PRISTINE CULTURE CATHETER Hml Medical, Inc. | KOD |
| Jul 14, 1989 | K892436 | KENDALL CURITY IRRIGATION SYRINGE The Kendal Co. | KOD |
| Jun 23, 1989 | K892691 | CATHETERS, MALE, FEMALE Zinnanti Surgical Instruments, Inc. | KOD |
| Jan 31, 1989 | K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR Coeur Laboratories, Inc. | KOD |
| Nov 18, 1988 | K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH Acme-Monaco Corp. | KOD |
| Aug 2, 1988 | K881981 | ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM Ryder Intl. Corp. | KOD |
| Aug 2, 1988 | K881781 | CATHETER STRAP Baxter Healthcare Corp | KOD |
| Jun 23, 1988 | K881363 | SYRINGE PREFILLED WITH WATER I M, Inc. | KOD |
| Jun 16, 1988 | K881646 | UROLOGICAL CATHETER Coeur Laboratories, Inc. | KOD |
| Mar 15, 1988 | K880100 | COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING Cook Urological, Inc. | KOD |
| Mar 9, 1988 | K875383 | LAKE CATHETER CARE KITS (MODIFICATION) Lake Medical Products, Inc. | KOD |
| Feb 11, 1988 | K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER Van-Tec, Inc. | KOD |
| Jan 27, 1988 | K874682 | MMG CATHETER PLUG W/DRAINAGE TUBE COVER Medical Marketing Group | KOD |
| Jan 6, 1988 | K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR Mon-A-Therm, Inc. | KOD |
| Dec 29, 1987 | K874312 | ACKRAD RETROGRADE URETHROGRAPHY SET Ackrad Laboratories | KOD |
| Dec 29, 1987 | K874293 | ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET Ackrad Laboratories | KOD |
| Dec 7, 1987 | K873448 | FOLEY CATHETER TEMPERATURE SENSOR Respiratory Support Products, Inc. | KOD |
| Dec 3, 1987 | K874517 | PHARMASEAL RUBBER URETHRAL CATHETER American Pharmaseal Div. Ahsc | KOD |
| Nov 13, 1987 | K873287 | IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) Todd Medical, Inc. | KOD |
| Oct 5, 1987 | K873435 | LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET Level 1 Technologies, Inc. | KOD |
| Sep 3, 1987 | K872750 | LAKE CATHETER CARE KIT Lake Medical Products, Inc. | KOD |
| Aug 10, 1987 | K871429 | ANTIMICROBIAL FOLEY CATHETER American Pharmaseal Div. Ahsc | KOD |
| Jun 24, 1987 | K864592 | JUDD URETHAL CATHETER CONTAINER Phil Judd, Inc. | KOD |
| Apr 17, 1987 | K870165 | FOLEY CATHETER Acorn Medical Products | KOD |
| Apr 10, 1987 | K871297 | KADIR HI-TORQUE GUIDE WIRE Argon Medical Corp. | KOD |
| Apr 1, 1987 | K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE American Pharmaseal Div. Ahsc | KOD |
| Mar 30, 1987 | K870557 | VAN-TEC PUMPING SYSTEM Van-Tec, Inc. | KOD |
| Mar 10, 1987 | K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER Van-Tec, Inc. | KOD |
| Dec 24, 1986 | K864736 | AKRO-SIL PLUS Akron Catheter, Inc. | KOD |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.