| Rusch Latex Gold Foley Catheter (K262056) | Teleflex Medical Sdn. Bhd. | 2026-08-05 |
| Rusch SoftSimplastic Foley Catheters (K252537) | Teleflex Medical Sdn. Bhd. | 2026-01-20 |
| Silicone Urethral Catheter (Silicone Urethral Catheter) (K243011) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 |
| InnoCare Specialty Foley Catheter (K241424) | Innocare Urologics, LLC | 2024-09-18 |
| Rüsch Latex Gold Foley Catheter (K232469) | Teleflexmedical, Inc. | 2024-08-01 |
| TraumaGuard Intra-abdominal Pressure Sensing System (K240057) | Sentinel Medical Technologies, LLC | 2024-04-17 |
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |
| 2-Way 100% Silicone Cleartract Catheter (K233013) | Silq Technologies Corporation | 2024-01-23 |
| Teleflex Rusch SoftSimplastic Foley Catheters (K212077) | Teleflexmedical, Inc. | 2023-07-27 |
| Flume Catheter (K231101) | Flume Catheter Company, Ltd. | 2023-06-29 |
| Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (K221020) | Potrero Medical, Inc. | 2023-01-13 |
| 2-Way 100% Silicone Cleartract Catheter (K222118) | Silq Technologies, Corp. | 2022-12-01 |
| 2-Way 100% Silicone ClearTract Catheter (K221625) | Silq Technologies Corporation | 2022-07-01 |
| FLUME catheter (K212151) | The Flume Catheter Company, Ltd. | 2021-11-03 |
| Well Lead All Silicone Foley Catheter with Temperature Sensor (K202134) | Well Lead Medical Co., Ltd. | 2021-04-08 |
| Foley Balloon Catheter for Urology (K201776) | Apollon Co., Ltd. | 2020-12-30 |
| Prefilled Syringe (K202698) | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 |
| HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc (K192034) | Pathway, LLC | 2020-04-21 |
| AquaFlate Pre-Filled Sterile Water Syringe 10mL (K200556) | H R Pharmaceuticals, Inc. | 2020-03-31 |
| Silicone Foley Catheter (K182463) | Biosensors International Pte, Ltd. | 2019-11-06 |
| Urethrotech UCD (K190060) | Urethrotech | 2019-10-04 |
| Signal Catheter (K182635) | Safe Medical Design | 2019-01-10 |
| PSM 3-Way Silicone Foley Catheter (K181616) | Pathway, LLC | 2018-09-21 |
| Bard Vertus Foley Catheter (K180781) | C.R. Bard, Inc. | 2018-09-19 |
| AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (K181814) | Amsino International, Inc. | 2018-09-04 |
| Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter (K173657) | Cook Incorporated | 2018-08-23 |
| CystoSure Plus Catheter (K181346) | Emmy Medical, LLC | 2018-08-06 |
| Yikang Latex Foley Catheter (K173340) | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 |
| Silicone Foley Catheter for single use (K172807) | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 |
| Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter (K173533) | Poiesis Medical, LLC | 2018-03-29 |
| Kohli Urinary Drainage Catheter (K172422) | Nellie Medical, LLC | 2018-02-09 |
| Rusch Silicone Foley Catheter (K161770) | Teleflexmedical, Inc. | 2017-05-05 |
| Rusch Simplastic Foley Catheters (K162989) | Teleflexmedical, Inc. | 2017-02-24 |
| Accuryn Monitoring System (K153655) | Potrero Medical, Inc. | 2016-04-15 |
| SilverCoat Silicone Foley Catheter (K150550) | Covalontechnologies, Inc. | 2015-11-24 |
| Bard LubriGuard Foley Catheter (K150699) | C.R. Bard, Inc. | 2015-07-28 |
| Medline Silicone Foley Catheter (K142635) | Medline Industries, Inc. | 2015-01-09 |
| WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER (K140667) | Well Lead Medical Co., Ltd. | 2014-12-15 |
| LIGHTHOUSE URINARY CATHETER (K140099) | Seedings Life Science Ventures, LLC | 2014-03-04 |
| LIGHTHOUSE(TM) URINARY CATHETER (K131655) | Seedings Life Science Ventures, LLC | 2013-11-04 |
| DISPOSABLE SILICONE FOLEY CATHETER (K130908) | Guangdong Baihe Medical Technology Co., Ltd. | 2013-10-03 |
| TEMPERATURE SENSOR CATHETER (K131020) | Degania Silicone , Ltd. | 2013-05-09 |
| DIRECTVISION CATHETER, UNCOATED (K110214) | Percuvision | 2011-05-27 |
| COUDE/ OR TIEMANN (K103371) | Degania Silicone , Ltd. | 2011-03-11 |
| AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER (K101824) | Amsino International, Inc. | 2010-09-13 |
| WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR (K091516) | Well Lead Medical Co., Ltd. | 2009-10-16 |
| 3 WAY SILICONE FOLEY BALLOON CATHETER (K091767) | Cook Urological, Inc. | 2009-10-09 |
| AMSURE HYDROPHILIC LATEX FOLEY CATHETER (K091699) | Amsino International, Inc. | 2009-08-10 |
| PERCUCATH URINARY CATHETER (K090262) | Percuvision, LLC | 2009-05-28 |
| UC-CARE POSITIONING SYSTEM (K082919) | Uc-Care Medical Systems, Ltd. | 2008-10-27 |
| WELL LEAD SILICONE AND LATEX FOLEY CATHETERS (K082815) | Well Lead Medical Instruments | 2008-10-08 |
| BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS (K070558) | C.R. Bard, Inc. | 2007-12-07 |
| BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS (K070582) | C.R. Bard, Inc. | 2007-12-07 |
| DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (K071049) | Tyco Healthcare | 2007-10-16 |
| MEDLINE LATEX FOLEY CATHETER (K071423) | Medline Industries, Inc. | 2007-07-18 |
| SUNMED FOLEY CATHETERS (K062112) | Sunmed, Inc. | 2007-06-04 |
| ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR (K063442) | Degania Silicone , Ltd. | 2007-03-26 |
| BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR (K070508) | C.R. Bard, Inc. | 2007-03-09 |
| MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. (K052168) | Medline Industries, Inc. | 2006-02-16 |
| ADVANCED UROLOGICAL CATHETER (K053429) | Entracare, LLC | 2006-02-08 |
| AMSURE 100% SILICONE FOLEY CATHETER (K051059) | Amsino International, Inc. | 2005-06-28 |
| BEAMCATH (K042110) | Beampoint AB | 2005-02-25 |
| DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (K042709) | Tyco Healthcare | 2005-01-18 |
| OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 (K041983) | Opticon Medical | 2004-11-17 |
| BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS (K040504) | C.R. Bard, Inc. | 2004-05-14 |
| OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 (K033830) | Opticon Medical, Inc. | 2004-01-09 |
| AMSURE FOLEY CATHETER (K030120) | Amsino International, Inc. | 2003-10-29 |
| VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES (K031748) | Vitalcare Group, Inc. | 2003-08-27 |
| DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER (K024010) | The Kendall Company Div. of Tyco Healthcare Group | 2003-06-11 |
| PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND (K030813) | Primary Care Solutions, Inc. | 2003-05-30 |
| VITALCARE FOLEY CATHETER (K021939) | Vitalcare, Inc. | 2003-04-22 |
| OPTION-VF URINARY CATHETER, FV14218 (K023090) | Opticon Medical, Inc. | 2003-03-19 |
| ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 (K021142) | Fortune Medical Instrument Corp. | 2002-10-01 |
| 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS (K022287) | 3t Medical Systems, LLC | 2002-09-23 |
| BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON (K002612) | C.R. Bard, Inc. | 2002-09-03 |
| ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) (K013276) | Sewoon Medical Co., Ltd. | 2002-02-15 |
| PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, (K013174) | Porges S.A. | 2002-01-04 |
| PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL (K013172) | Porges S.A. | 2001-12-20 |
| DRAINAGE CATHETER OR FOLEY CATHETER (K010006) | Applied Medical Resources Corp. | 2001-07-25 |
| MENTOR SELF-CATH PLUS (K003784) | Mentor Corp. | 2001-03-05 |
| BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU (K003289) | C.R. Bard, Inc. | 2001-01-05 |
| BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER (K002868) | C.R. Bard, Inc. | 2000-12-08 |
| RUSCH BRILLANT SILICONE FOLEY (K993063) | Rusch Intl. | 1999-12-09 |
| KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C (K990500) | The Kendal Co. | 1999-09-28 |
| OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 (K990509) | Implemed, Inc. | 1999-05-18 |
| BARDEX LUBRI-SIL FOLEY CATHETER (K984084) | Bard Medical Div. | 1999-02-01 |
| MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER (K982970) | Mri Manufacturing and Research, Inc. | 1998-10-28 |
| EUROMEDICAL HAEMATURIA FOLEY CATHETER (K973076) | Unomedical Sdn Bhd | 1998-09-16 |
| URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 (K982626) | Medworks Corp. | 1998-08-20 |
| ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER (K981612) | Rochester Medical Corp. | 1998-07-08 |
| RUSCH SILICONE FOLEY CATHETER (K980870) | Rusch, Inc. | 1998-06-09 |
| ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER (K980919) | Fortune Medical Instrument Corp. | 1998-03-31 |
| RUSCH SIMPLASTIC COUNCILL TIP CATHETER (K974419) | Rusch, Inc. | 1998-01-27 |
| RUSCH BRILLANT SILICONE FOLEY CATHETER (K972184) | Rusch Intl. | 1998-01-08 |
| RUSCH BRILLANT BALLOON CATHETER (K971643) | Rusch Intl. | 1997-10-07 |
| LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (K971796) | Louisville Laboratories, Inc. | 1997-08-12 |
| LAPAROTOMY BLADDER NECK SUSPENSION KIT (K971801) | Louisville Laboratories, Inc. | 1997-07-22 |
| CONTIDRAIN CATHETER (K964757) | Contimed, Inc. | 1997-06-25 |
| OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (K970716) | Opticon Medical, Inc. | 1997-05-16 |
| SYMPACATH HYDROGEL COATED FOLEY (K964575) | Rusch Intl. | 1997-02-04 |