| NEXT GENERATION SALEM SUMP (K040388) | Kendall | 2004-05-17 |
| STEP-TIP CHRONIC HEMODIALYSIS CATHETER (K040666) | Arrow International, Inc. | 2004-05-14 |
| BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS (K040504) | C.R. Bard, Inc. | 2004-05-14 |
| APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR (K041131) | Apple Medical Corp. | 2004-05-13 |
| Y2K2 ENTERNAL FEEDING MANAGER (K030413) | Moss Medical Products | 2004-05-11 |
| MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS (K041032) | Orbus Medical Technologies | 2004-05-10 |
| VIADUCT MINISCOPE AND ACCESSORIES (K040949) | Acueity, Inc. | 2004-05-07 |
| USW NEEDLEKNIFE PAPILLOTOME (K040981) | Wilson-Cook Medical, Inc. | 2004-05-07 |
| EASY CORE BIOPSY SYSTEM (K040893) | Boston Scientific Corp | 2004-05-06 |
| INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 (K040948) | Intuitive Surgical, Inc. | 2004-05-05 |
| SENORX BIOPSY DEVICE II (K040842) | Senorx, Inc. | 2004-04-30 |
| TRIPTER X-1 COMPACT (K040470) | Direx Systems Corp. | 2004-04-28 |
| PARAMOUNT MINI GPS BILIARY STENT SYSTEM (K040653) | Ev3, Inc. | 2004-04-28 |
| ENDOMAT LC PUMP, MODEL 20 3303 20 (K031457) | KARL STORZ Endoscopy-America, Inc. | 2004-04-28 |
| AQUADEX SYSTEM 100, MODEL A1100 (K040489) | Chf Solutions, Inc. | 2004-04-27 |
| RENACLEAN SH DIALYZER CLEANING SYSTEM (K033505) | Minntech Corp. | 2004-04-27 |
| BICARD MIXING SYSTEM (K030366) | Dialysis Systems, Inc. | 2004-04-19 |
| ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT (K040402) | AngioDynamics, Inc. | 2004-04-19 |
| ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 (K040509) | Spire Biomedical, Inc. | 2004-04-19 |
| PIGGYBACK IRRIGATING SYSTEM (K040094) | Kosin Technologies, LLC | 2004-04-15 |
| VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM (K040215) | Vision-Sciences, Inc. | 2004-04-15 |
| CONVATEC FECAL MANAGEMENT SYSTEM (K032734) | Convatec, A Bristol-Myers Squibb Co. | 2004-04-08 |
| ONEVIEW INTERFACE (K040074) | Nxstage Medical, Inc. | 2004-04-08 |
| XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 (K040667) | Abbott Laboratories | 2004-04-07 |
| COOK URETERAL BALLOON DILATION CATHETER SET (K040127) | Cook Urological, Inc. | 2004-04-06 |
| HEMOCLEAN (K023064) | Krd Co., Ltd. | 2004-04-06 |
| CUSTODIOL (K032794) | Dr. Franz Kohler Chemie GmbH | 2004-04-05 |
| NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL (K030784) | Applied Medical Technology, Inc. | 2004-04-01 |
| RABBIT (K040087) | Scion International, Inc. | 2004-04-01 |
| BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM (K040027) | Boston Scientific | 2004-03-30 |
| MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 (K040244) | The Microoptical Corporation | 2004-03-24 |
| EASY LOOP, MODEL EZL-01 (K040110) | Tools For Surgery, LLC | 2004-03-24 |
| ENDOBOY (K033644) | Geyser S.A. | 2004-03-24 |
| ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (K033149) | Ultimate Concepts, Inc. | 2004-03-23 |
| SOLAR GI SYSTEM (K031084) | Medical Measurement Systems B.V. | 2004-03-19 |
| SHAPE LOCKING ENDOSCOPIC OVERTUBE (K033954) | Usgi Medical, Inc. | 2004-03-19 |
| LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS (K040550) | Orbus Medical Technologies | 2004-03-16 |
| VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER (K040492) | Boston Scientific Corp | 2004-03-16 |
| ZILVER 635 BILIARY STENT (K040505) | Cook, Inc. | 2004-03-16 |
| TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 (K040447) | Boston Scientific Corp | 2004-03-12 |
| SOHNIKS (K033191) | Sohniks Endoscopy, Inc. | 2004-03-09 |
| COLONOSIGHT MODEL 510B (K032688) | Sightline Technologies , Ltd. | 2004-03-05 |
| INTEGRAL HEMODIALYSIS CATHETER (K040260) | Arrow Int'L. | 2004-03-05 |
| PAJUNK MODULAR HANDLE INSTRUMENTS (K033249) | Pajunk GmbH | 2004-03-05 |
| NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE (K033842) | Vernon-Carus Limited | 2004-03-04 |
| B.BRAUN PREMIXED DIALYSATE (K034066) | B.Braun Medical, Inc. | 2004-03-03 |
| PLUME SAFETY AVF NEEDLE (K040247) | Jms North America Corp. | 2004-03-03 |
| ATRION MEDICAL QL INFLATION DEVICE (K032840) | Atrion Medical Products, Inc. | 2004-03-03 |
| TRAPMATIC SYSTEM SET (K033616) | H.S Hospital Service S.P.A | 2004-03-01 |
| CONDUCTIVITY/TDS CALIBRATOR SOLUTION (K033330) | Mesa Laboratories, Inc. | 2004-02-27 |
| TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING (K040129) | Wilson-Cook Medical, Inc. | 2004-02-27 |
| PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER (K033676) | Kendall | 2004-02-20 |
| MAMMOTOME EX HAND HELD SYSTEM (K033700) | Ethicon Endo-Surgery, Inc. | 2004-02-20 |
| WILSON-COOK USW CAP AND WIRE LOCK (K040137) | Wilson-Cook Medical, Inc. | 2004-02-20 |
| OASIS BILIARY STENT INTRODUCTION SYSTEM (K040151) | Wilson-Cook Medical, Inc. | 2004-02-20 |
| PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 (K032958) | United Medical Systems, Inc. | 2004-02-17 |
| MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K040248) | Given Imaging , Ltd. | 2004-02-17 |
| WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM (K033909) | Abbott Laboratories | 2004-02-17 |
| CANNON II PLUS (K040078) | Arrow International, Inc. | 2004-02-13 |
| MOSSMED DUAL INTERMITTENT ASPIRATOR (K031492) | Moss Medical Products | 2004-02-05 |
| AMSURE RED RUBBER URETHRAL CATHETER (K030293) | Amsino International, Inc. | 2004-02-04 |
| BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM (K033497) | C.R. Bard, Inc. | 2004-02-04 |
| BARD TIGERTAIL URETERAL CATHETER (K033719) | C.R. Bard, Inc. | 2004-02-04 |
| DURAMAX .018 BILIARY STENT SYSTEM (K032436) | Avantec Vascular Corp. | 2004-02-04 |
| FRESENIUS ULTRAFLO HPX HEMODIALYZER (K034064) | Fresenius Medical Care North America | 2004-01-30 |
| OLYMPUS VIDEO URETEROSCOPE, NTSC (K033651) | Olympus Winter & Ibe GmbH | 2004-01-30 |
| MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (K031617) | Mediplus , Ltd. | 2004-01-16 |
| BARD ELIMINATOR PET BALLOON DILATORS (K033936) | C.R. Bard, Inc. | 2004-01-14 |
| OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (K031147) | Ethicon Endo-Surgery, Inc. | 2004-01-12 |
| CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT (K032710) | Apogee Medical, Inc. | 2004-01-09 |
| OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 (K033830) | Opticon Medical, Inc. | 2004-01-09 |
| OMNILINK .018 BILIARY STENT SYSTEM (K033834) | Guidant Corp. | 2004-01-02 |
| MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT (K033778) | C.R. Bard, Inc. | 2003-12-30 |
| TRACER METRO SMART WIRE GUIDE (K033754) | Wilson-Cook Medical, Inc. | 2003-12-30 |
| SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 (K033317) | Opus Medical, Inc. | 2003-12-30 |
| ATHENA PELVIC MUSCLE TRAINER II (K033256) | Athena Feminine Technologies, Inc. | 2003-12-30 |
| HEMEDEX FIXATION DEVICE (K032127) | Hemedex Incorporated | 2003-12-30 |
| STERICHEK BICARB PH REAGENT STRIPS (K031267) | Environmental Test Systems, Inc. | 2003-12-23 |
| IRRIGATION CHANNEL TUBING, MODEL 100135 (K033695) | Byrne Medical, Inc. | 2003-12-23 |
| INTERMITTENT URETHRAL CATHETERS (K033023) | Rusch Intl. | 2003-12-23 |
| DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K031689) | Chf Solutions, Inc. | 2003-12-23 |
| DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (K032061) | Spire Biomedical, Inc. | 2003-12-23 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K033394) | Cordis Corp. | 2003-12-22 |
| DEGALL II GALLBLADDER EXTRACTOR (K033359) | Surgicon, Inc. | 2003-12-19 |
| WILSON-COOK TRI-TOME SELECT PLUS (K033203) | Wilson-Cook Medical, Inc. | 2003-12-19 |
| STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS (K032943) | Stryker Corp. | 2003-12-17 |
| ZILVER 518 BILIARY STENT (K033348) | Cook, Inc. | 2003-12-15 |
| FASTRAC GASTRIC ACCESS PORT KIT (K033562) | C.R. Bard, Inc. | 2003-12-12 |
| MOTILITY VISUALIZATION SYSTEM (K031169) | Sierra Scientific Instruments, Inc. | 2003-12-12 |
| ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD (K033269) | Ethicon Endo-Surgery, Inc. | 2003-12-10 |
| SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 (K033537) | Abbott Laboratories | 2003-12-10 |
| LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA (K023023) | Vasca, Inc. | 2003-12-04 |
| ELPHA 4 CONTI (K032988) | Danmeter A/S | 2003-12-03 |
| HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER (K033294) | C.R. Bard, Inc. | 2003-11-26 |
| FOSSA URETERAL OPEN LUMEN STENT (K033368) | Fossa Medical, Inc. | 2003-11-26 |
| NXSTAGE PUREFLOW SOLUTION (K033386) | Nxstage Medical, Inc. | 2003-11-26 |
| LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS (K033335) | Siemens Medical Solutions USA, Inc. | 2003-11-25 |
| SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K032598) | Synergetics, Inc. | 2003-11-24 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314) | Ev3, Inc. | 2003-11-21 |
| SYSTEM 100 ULTRAFILTRATION CATHETER (K023874) | Chf Solutions, Inc. | 2003-11-20 |