| Transurethral Catheter Safety Valve (TUCSV) (80050) (K260919) | Class Medical , Ltd. | 2026-08-05 |
| Bi-Flex Evo (K182144) | Promepla Sam | 2018-09-07 |
| Vesair Cystoscopic Sheath (K162356) | Solace Therapeutics | 2017-03-02 |
| BI-FLEX URETERAL ACCESS SHEATH (K140441) | Promepla Sam | 2014-06-17 |
| WIJAY EZ-VOID EXTERNAL CATHETER VALVE (K140562) | Leomed, LLC | 2014-06-16 |
| GUARDIAN URETHRAL SHEATH (K141252) | Solace Therapeutics | 2014-06-09 |
| GUARDIAN URETHRAL SHEATH (K131803) | Solace Therapeutics | 2013-08-20 |
| VARI-PASS VARIABLE LENGTH ACCESS SHEATH (K123170) | Olympus Surgical Technologies America | 2013-02-04 |
| ROCAMED ROCAUS PLATINUM (K120160) | Promepla Sam | 2012-05-14 |
| PREFILLED CATHETER INFLATION SYRINGE (K112209) | Avail Medical Products, Inc. | 2011-09-08 |
| PRE-FILLED CATHETER INFLATION SYRINGE (K090121) | Avail Medical Products, Inc. | 2009-04-15 |
| CYSTOGLIDE INTRODUCER SHEATH (K052298) | Percutaneous Systems, Incorporated | 2006-12-12 |
| CAREVENT (K062240) | Chief Medical, LLC | 2006-10-16 |
| CATHASSIST (K052952) | Physician Technologies, Inc. | 2006-05-14 |
| CYSTOGLIDE DILATING INTRODUCER SHEATH (K052134) | Percutaneous Systems, Inc. | 2005-09-22 |
| UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (K051593) | Acmi Corporation | 2005-09-02 |
| UPDATED SLIP UROLOGY INTRODUCER SHEATH (K042531) | Percutaneous Systems, Incorporated | 2005-02-01 |
| MICROVERTER URETERAL ACCESS SHEATH (K042877) | Percutaneous Systems, Inc. | 2004-11-16 |
| SLIP UROLOGY INTRODUCER SHEATH (K040520) | Percutaneous Systems, Inc. | 2004-05-20 |
| HEMEDEX FIXATION DEVICE (K032127) | Hemedex Incorporated | 2003-12-30 |
| CATHETER CONNECTOR (K023690) | World Metals, Inc. | 2003-02-28 |
| MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 (K000767) | Memcath Technologies, LLC | 2000-06-05 |
| PBN DRAINAGE CATHETER GUIDEWIRES (K991097) | Medical Device Technologies, Inc. | 1999-04-23 |
| SNAP-N-PEEL INTRODUCERS (K981611) | Circon Corp. | 1998-07-30 |
| HYDROPHILIC COATED GUIDEWIRE (K981667) | Lake Region Mfg., Inc. | 1998-06-05 |
| MANAN MANTA CATHETER FIXATION DISK (K981229) | Medical Device Technologies, Inc. | 1998-04-22 |
| INSULATOR WIRE GUIDE (K972977) | Cook Urological, Inc. | 1997-10-10 |
| LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. (K960866) | Lake Region Mfg., Inc. | 1996-04-05 |
| MANAN MANTA CATHETER FIXATION DISK (K954132) | Manan Medical Products, Inc. | 1996-03-26 |
| PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (K952414) | Acacia Laboratories, Inc. | 1995-06-23 |
| KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR (K951995) | Karl Storz Endoskop GmbH | 1995-05-24 |
| KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (K951488) | The Kendal Co. | 1995-04-25 |
| PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (K943835) | Orion Life Systems, Inc. | 1995-01-24 |
| AMPLATZ SUPER STIFF GUIDEWIRE (K944754) | Boston Scientific Corp | 1994-10-07 |
| UROLOGICAL GUIDWIRE (K944135) | Applied Medical Resources | 1994-09-21 |
| CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM (K934072) | Contour Fabricators of Florida, Inc. | 1994-09-08 |
| ZEBRA UROLOGICAL GUIDEWIRE (K942205) | Boston Scientific Corp | 1994-07-07 |
| FLEXFINDER GUIDEWIRE (K942074) | Flexmedics | 1994-06-24 |
| SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE (K935643) | Regulatory & Marketing Services, Inc. | 1994-06-10 |
| FLEXI-TRAK ANCHORING DEVICE (K932143) | Convatec, A Division of E.R. Squibb & Sons | 1993-12-01 |
| FOLEY CATHETER TRAY (K931013) | Kit Pak, Inc. | 1993-08-09 |
| GUIDE-TECH ENCAPSULATED GUIDEWIRE (K926039) | Cape Tech Medical Products | 1993-08-05 |
| NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO (K925161) | North American Sterilization & Packaging Co. | 1993-07-21 |
| URINARY CARE SUPPLIES (K923496) | Orion Life Systems, Inc. | 1993-05-27 |
| KIT PAK URINARY CARE SUPPLIES (K925281) | Kit Pak, Inc. | 1993-04-19 |
| HYDROPHILIC COATED GUIDEWIRE (K926344) | Surgitek | 1993-03-05 |
| GUIDEWIRE (K921200) | Lake Region Mfg., Inc. | 1992-09-04 |
| KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER (K921055) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1992-05-11 |
| MENTOR INFUSION LINE (K912919) | Mentor Corp. | 1991-12-13 |
| CATH CONTROL (K914211) | Highpoint Medical Corp. | 1991-11-22 |
| UNIVERSAL SWIVEL PATCH (K913679) | Bryman Medical | 1991-09-05 |
| URETERAL CATHETER HOLDER (K912146) | Inman Liebelt Corp. | 1991-07-26 |
| FLEXI-TRAK(TM) ANCHORING DEVICE (K905128) | Convatec, A Division of E.R. Squibb & Sons | 1990-11-29 |
| MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS (K900031) | Porges Corp. | 1990-03-06 |
| CATHETER PLUG/PROTECTOR (K896806) | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-26 |
| PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE (K890072) | Medireach, Inc. | 1989-06-12 |
| O'NEIL URINARY CATHETER INTRODUCER (K884819) | Medical Marketing Group | 1989-02-17 |
| CATHETER WITHDRAWAL UNIT (K881878) | Eris Medical Technology | 1988-07-28 |
| TECNOL CATHETER LEG STRAP (K882641) | Tecnol New Jersey Wound Care, Inc. | 1988-07-12 |
| CLOSED FOLEY CATHETER SYSTEM (K873288) | Todd Medical, Inc. | 1987-11-27 |
| DEFLECTING GUIDE WIRE (K833242) | Van-Tec, Inc. | 1983-10-19 |
| TRANSENDOSCOPIC INJECTION CATHETER TEI (K821336) | Sounson Research Co., Inc. | 1982-05-21 |
| URINARY DRAINAGE BAG (K781987) | Kelsar Corp. | 1978-12-04 |
| SAFEED DISP. PLASTIC CATHETER (K771212) | Terumo America, Inc. | 1977-09-12 |
| SILASTIC BRAND GASTRIC LAVAGE TUBE (K760943) | Dow Corning Corp. Healthcare Industries Materials | 1976-11-23 |