| FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 (K042076) | Fujinon, Inc. | 2004-11-18 |
| OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 (K041983) | Opticon Medical | 2004-11-17 |
| MICROVERTER URETERAL ACCESS SHEATH (K042877) | Percutaneous Systems, Inc. | 2004-11-16 |
| STERICHEK GLUTARALDEHYDE REAGENT STRIPS (K040660) | Hach Company | 2004-11-15 |
| GENICON SUCTION IRRIGATION SYSTEM (K041967) | Genicon | 2004-11-12 |
| INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT (K042855) | Intuitive Surgical, Inc. | 2004-11-12 |
| FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 (K041903) | Fujinon, Inc. | 2004-11-10 |
| ENTERYX INJECTION CATHETER (K042882) | Boston Scientific Corp | 2004-11-09 |
| VASC-ALERT (K042566) | Vasc-Alert, Inc. | 2004-11-08 |
| MAMMOTOME MR BIOPSY SYSTEM (K042753) | Ethicon Endo-Surgery, Inc. | 2004-11-08 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K042969) | Cordis Corp. | 2004-11-08 |
| CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE (K042615) | Carbon Medical Technologies, Inc. | 2004-11-05 |
| KENDALL CO2NFIRM NOW CO2 DETECTOR (K042572) | Kendall | 2004-11-05 |
| K.E.P. CONNECTOR AND CLIP (K042900) | K.E.P., LLC | 2004-11-05 |
| BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER (K041464) | Busse Hospital Disposables | 2004-11-05 |
| INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM (K042069) | Acmi Corporation | 2004-11-01 |
| GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A (K040301) | Gambro Renal Products | 2004-11-01 |
| MENTOR GENESIS PENILE PROSTHESIS (K040959) | Mentor Corp. | 2004-10-29 |
| SCB/VALLEYLAB FORCE FX INTERFACE UNIT (K041912) | KARL STORZ Endoscopy-America, Inc. | 2004-10-25 |
| GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE (K041149) | Given Imaging , Ltd. | 2004-10-25 |
| URO PRO (K042457) | W.O.M. World of Medicine AG | 2004-10-25 |
| AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM (K042300) | Applied Medical Technology, Inc. | 2004-10-25 |
| RM3 RENAL PRESERVATION SYSTEM (K042224) | Waters Instruments, Inc. | 2004-10-22 |
| MEGA PURE CART (K031832) | Mega Services | 2004-10-20 |
| EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE (K042741) | Pentax Medical Company | 2004-10-19 |
| ISC-1000 PENTAX CONFOCAL LASER SYSTEM (K042740) | Pentax Medical Company | 2004-10-19 |
| MODIFICATION TO URETERAL STENT (K040760) | Applied Medical Resources Corp. | 2004-10-15 |
| TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K042561) | Fmd, LLC | 2004-10-12 |
| GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS (K041005) | Gambro Renal Products | 2004-10-07 |
| ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES (K041163) | Isopure, Corp. | 2004-10-07 |
| VACUUM ASSISTED CORE BIOPSY DEVICE (K042290) | Suros Surgical Systems, Inc. | 2004-10-06 |
| VARICES NEEDLE (K031238) | Scandimed. A.S. | 2004-10-04 |
| ZILVER 518 BILIARY STENT (K042518) | Cook, Inc. | 2004-10-01 |
| XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 (K041962) | Abbott Laboratories | 2004-10-01 |
| V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (K042464) | Medical Device Technologies, Inc. | 2004-09-30 |
| BARDEX I.C. LATEX FOLEY CATHETER (K040658) | C.R. Bard, Inc. | 2004-09-29 |
| PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (K041914) | Kendall | 2004-09-27 |
| MODIFIED SPACEMAKER SYSTEM (K042412) | United States Surgical, A Division of Tyco Healthc | 2004-09-24 |
| FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 (K041792) | Fresenius Medical Care North America | 2004-09-24 |
| DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER (K042016) | Datascope Corp. | 2004-09-23 |
| CAVERMAP SURGICAL AID (K041732) | Blue Torch Medical Technologies | 2004-09-21 |
| MEDCOMP T-3 (K033570) | Medcomp | 2004-09-16 |
| MODIFICATION TO OPTICAL SEPARATOR SYSTEM (K041795) | Applied Medical Resources Corp. | 2004-09-14 |
| 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K041791) | Chf Solutions, Inc. | 2004-09-10 |
| ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K042225) | Acmi Corporation | 2004-09-10 |
| SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM (K042136) | Sanarus Medical, Inc. | 2004-09-08 |
| VACUUM ASSISTED CORE BIOPSY DEVICE (K034021) | Suros Surgical Systems, Inc. | 2004-09-08 |
| STRYKER SWITCHPOINT INFINITY (K033132) | Stryker Communications Corp. | 2004-09-02 |
| SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) (K041034) | Entracare, LLC | 2004-08-31 |
| NXSTAGE PUREFLOW-B SOLUTION (K042045) | Nxstage Medical, Inc. | 2004-08-27 |
| B. BRAUN BICARBONATE DIALYSATE (K041683) | B.Braun Medical, Inc. | 2004-08-27 |
| ACCUSOL DIALYSIS SOLUTION (K041428) | Baxter Healthcare Corp | 2004-08-27 |
| USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (K031502) | Usfilter | 2004-08-27 |
| STORZ MODULITH, MODEL SLX-F2 (K040476) | KARL STORZ Endoscopy-America, Inc. | 2004-08-26 |
| NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (K041573) | Nanma Mfg Co., Ltd. | 2004-08-25 |
| MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT (K042204) | Ev3, Inc. | 2004-08-23 |
| ULTRASOUND LOCALIZATION SYSTEM ULS 0142 (K040741) | Hmt High Medical Technologies AG | 2004-08-19 |
| MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (K041610) | Richard Wolf Medical Instruments Corp. | 2004-08-19 |
| OLYMPUS BF TYPE UC160-OL8 (K042140) | Olympus Corporation | 2004-08-18 |
| JMS BLOOD TUBING SETS (K032975) | Jms North America Corp. | 2004-08-16 |
| PERFORMANCE WATER TREATMENT SYSTEM (K033648) | Performance Water Systems, LLC | 2004-08-09 |
| STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM (K033135) | Stryker Endoscopy | 2004-08-09 |
| DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 (K041827) | Boston Scientific Corp | 2004-08-06 |
| PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K041796) | Cordis Corporation | 2004-08-03 |
| 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 (K041559) | Spire Biomedical, Inc. | 2004-07-30 |
| 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 (K040992) | Medcomp | 2004-07-29 |
| HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX (K041726) | Asahi Medical Co., Ltd. | 2004-07-23 |
| COOK SIDEARM CORE TISSUE BIOPSY DEVICE (K041544) | Urological, Inc. | 2004-07-22 |
| VIABIL BILIARY ENDOPROSTHESIS (K041423) | W. L. Gore & Associates, Inc. | 2004-07-21 |
| DOVER ROB-NEL CATHETER (K040897) | Tyco Healthcare | 2004-07-20 |
| CORE NEEDLE BIOPSY (K040266) | Remington Medical, Inc. | 2004-07-09 |
| INJECTOR NEEDLE/SNARE (K040961) | United States Endoscopy Group, Inc. | 2004-07-08 |
| DOVER RED RUBBER ROBINSON CATHETER (K041243) | Tyco Healthcare | 2004-07-07 |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K040237) | Intuitive Surgical, Inc. | 2004-07-07 |
| MODIFICATION TO TRIPTER X-1 COMPACT DUET (K041582) | Direx Systems Corp. | 2004-07-07 |
| EXTRACTOR RX RETRIEVAL BALLOON (K041606) | Boston Scientific Corp | 2004-07-07 |
| EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (K041416) | Deroyal | 2004-07-02 |
| H&S-CONDUCTIVITY STANDARD SOLUTION (K041636) | H & S Technical Services | 2004-07-02 |
| NXSTAGE SYSTEM ONE (K041424) | Nxstage Medical, Inc. | 2004-07-02 |
| ZILVER BILIARY STENT SYSTEM USW (K040930) | Wilson-Cook Medical, Inc. | 2004-07-02 |
| OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 (K041494) | Olympus Corporation | 2004-07-01 |
| DAVOL DELIVERY SYSTEM (K041641) | C.R. Bard, Inc. | 2004-07-01 |
| BIPRO MODEL SDS-CB200 (K033118) | Medical Solutions International | 2004-06-28 |
| WILOSN-COOK BILIARY DILATION BALLOON (K040800) | Wilson-Cook Medical, Inc. | 2004-06-25 |
| LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K041370) | Orbus Medical Technologies | 2004-06-24 |
| CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 (K040494) | United States Endoscopy Group, Inc. | 2004-06-23 |
| ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (K041108) | Iscience Surgical Corporation | 2004-06-22 |
| CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K040413) | Cordis Europa, N.V. | 2004-06-21 |
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |
| DISPOSABLE OVERTUBE (K040836) | United States Endoscopy Group, Inc. | 2004-06-10 |
| FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM (K040048) | Fujinon, Inc. | 2004-06-07 |
| INNERVUE DIAGNOSTIC SCOPE SYSTEM (K040604) | Arthrotek, Inc. | 2004-06-04 |
| MODIFICATION TO NXSTAGE SYSTEM ONE (K040696) | Nxstage Medical, Inc. | 2004-05-26 |
| ECONOLITH E3000, MODEL 3000 (SW-6) (K040461) | Medispec, Ltd. | 2004-05-25 |
| POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE (K040255) | Gambro Renal Products, Inc. | 2004-05-24 |
| SLIP UROLOGY INTRODUCER SHEATH (K040520) | Percutaneous Systems, Inc. | 2004-05-20 |
| SLIP UROLOGY CATHETER (K040519) | Percutaneous Systems, Inc. | 2004-05-20 |
| WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH (K040324) | Wilson-Cook Medical, Inc. | 2004-05-20 |
| TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR (K041006) | Kendall | 2004-05-19 |
| VAXCEL PLUS CHRONIC DIALYSIS CATHETER (K040736) | Boston Scientific Corp | 2004-05-18 |