| IMBIBE BONE MARROW ASPIRATION NEEDLE (K050795) | Orthovita, Inc. | 2005-06-03 |
| OMNITECH FULGURATING ELECTRODE (K050454) | Omnitech Systems, Inc. | 2005-05-27 |
| PROCON2 (K042431) | Incontinent Control Devices, Inc. | 2005-05-27 |
| POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (K043342) | Gambro Renal Products | 2005-05-27 |
| MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (K033262) | Gambro Renal Products | 2005-05-27 |
| U-BALLOON DILATION CATHETER (K050875) | C.R. Bard, Inc. | 2005-05-26 |
| REPROCESSED ENDOSCOPIC TROCAR (K043592) | Sterilmed, Inc. | 2005-05-23 |
| XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050534) | Abbott Laboratories | 2005-05-20 |
| ENCOR 7 GAUGE (K051158) | Senorx, Inc. | 2005-05-16 |
| NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 (K050650) | Cytyc Surgical Products | 2005-05-16 |
| ARMAND ENDOSCOPE HOLDER (K050051) | KLS-Martin L.P. | 2005-05-16 |
| SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 (K050503) | Olympus Medical Systems Corporation | 2005-05-12 |
| WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE (K043203) | Wilson-Cook Medical, Inc. | 2005-05-11 |
| NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM (K050829) | Conmed Integrated Systems (Cmis) | 2005-05-06 |
| ANTI-I.V. ENTERAL FEEDING SYSTEM (K043044) | Viasys Medsystems | 2005-05-06 |
| ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER (K050874) | Astra Tech, Inc. | 2005-05-05 |
| 90XL INSTRUMENTATION SYSTEM (K050812) | Mesa Laboratories, Inc. | 2005-05-05 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |
| COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE (K050578) | Cook Ireland, Ltd. | 2005-04-22 |
| PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 (K050777) | Conmedcorp | 2005-04-22 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT (K050725) | Ev3 Corporation | 2005-04-20 |
| ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM (K042018) | Simply Clean Air & Water, Inc. | 2005-04-15 |
| EVADRI BLADDER CONTROL SYSTEMS (K050483) | Hollister, Inc. | 2005-04-12 |
| VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (K043253) | Vanguard Medical Concepts, Inc. | 2005-04-08 |
| TEGRESS IMPLANT NEEDLE (K050688) | C.R. Bard, Inc. | 2005-04-06 |
| AIDA WITH DICOM AND HL7 INTERFACE (K043324) | KARL STORZ Endoscopy-America, Inc. | 2005-04-04 |
| TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES (K050488) | Prosurg, Inc. | 2005-04-01 |
| COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH (K043418) | Cook Urological, Inc. | 2005-03-31 |
| VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (K043594) | Vanguard Medical Concepts, Inc. | 2005-03-31 |
| FRESENIUS LIBERTY CYCLER (K043363) | Fresenius Medical Care North America | 2005-03-31 |
| LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM (K050639) | Lumenis, Inc. | 2005-03-31 |
| COOK IRELAND SONNET POLYPECTOMY SNARE (K050294) | Cook Ireland, Ltd. | 2005-03-31 |
| MODIFICATION TO:ZILVER 518 BILIARY STENT (K050698) | Cook, Inc. | 2005-03-30 |
| HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE (K050163) | Henke Sass Wolf of America, Inc. | 2005-03-24 |
| 14F DUAL FLOATING DIALYSIS CATHETER/TRAY (K042672) | Cardio Med Supplies, Inc. | 2005-03-23 |
| DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM (K043344) | Dialysis Services, Inc. | 2005-03-23 |
| LIFESTENT TURBO BILIARY STENT SYSTEMS (K050627) | Edwards Lifesciences, LLC | 2005-03-22 |
| RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES (K042523) | Richard Wolf Medical Instruments Corp. | 2005-03-18 |
| NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (K043436) | Nxstage Medical, Inc. | 2005-03-17 |
| HEMOCATH (K043292) | Med-Conduit, Inc. | 2005-03-16 |
| STRYKER URETEROSCOPE (K043021) | Stryker Endoscopy | 2005-03-16 |
| TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) (K050091) | Direx Systems Corp. | 2005-03-16 |
| ENDOMARK STERILE INDIA INK (K042901) | Pmt Corp. | 2005-03-16 |
| STRYKER FLEXIBLE CYSTONEPHROSCOPE (K043022) | Stryker Endoscopy | 2005-03-15 |
| PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (K050112) | Prime Pacific Health Innovations Corporation | 2005-03-15 |
| EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K040883) | Advanced Sterilization Products | 2005-03-15 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |
| RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR (K050232) | Boston Scientific Corp | 2005-03-11 |
| ENDOLINK TRUE MOVEMENT SYSTEM (K043541) | Novare Surgical Systems, Inc. | 2005-03-10 |
| WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K042797) | Gambro Renal Products | 2005-03-09 |
| FX WIRE ADVANCED MEASUREMENT GUIDEWIRE (K050304) | Conmedcorp | 2005-03-08 |
| SPYGLASS DIRECT VISULATION PROBE (K050403) | Boston Scientific Corp | 2005-03-04 |
| MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K043288) | Intuitive Surgical, Inc. | 2005-03-03 |
| DUAL LUMEN CATHETER (K043581) | Acmi Corporation | 2005-03-03 |
| USGI SHAPELOCK ENDOSCOPIC GUIDE (K050253) | Usgi Medical | 2005-02-28 |
| MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K041884) | Mueller Water Conditioning, Inc. | 2005-02-28 |
| CUSTODIOL (K043461) | Dr. Franz Kohler Chemie GmbH | 2005-02-28 |
| BEAMCATH (K042110) | Beampoint AB | 2005-02-25 |
| ENDOASSIST (K043284) | Armstrong Healthcare Limited | 2005-02-25 |
| XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050103) | Abbott Laboratories | 2005-02-16 |
| MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (K042659) | Medisiss | 2005-02-14 |
| BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK (K033862) | Bioteque Corp. | 2005-02-14 |
| MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR (K042834) | Micromedics, Inc. | 2005-02-11 |
| INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (K043523) | Medical Device Technologies, Inc. | 2005-02-11 |
| PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH (K043254) | Onset Medical Corporation | 2005-02-10 |
| EASY CORE BIOPSY SYSTEM II (K050120) | Boston Scientific Corp | 2005-02-08 |
| INSCOPE 3-STAGE BALLOON DILATOR (K043605) | Cordis Europa, N.V. | 2005-02-04 |
| ASSIST HEADER CLEANER (K043126) | Alcavis International, Inc. | 2005-02-03 |
| NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (K042780) | Prosurg, Inc. | 2005-02-03 |
| MEDCOMP SPLIT-CATH II (K040318) | Medcomp | 2005-02-03 |
| UPDATED SLIP UROLOGY INTRODUCER SHEATH (K042531) | Percutaneous Systems, Incorporated | 2005-02-01 |
| INFANT FEEDING TUBE (K042112) | Marian Medical, Inc. | 2005-01-28 |
| EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 (K043487) | Aizu Olympus Co., Ltd. | 2005-01-28 |
| LAPAROCISION SCOPE CONTROLLER SYSTEM (K050027) | Gmp/Companies, Inc. | 2005-01-27 |
| VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594) | Vanguard Medical Concepts, Inc. | 2005-01-25 |
| INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 (K050005) | Intuitive Surgical, Inc. | 2005-01-25 |
| DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (K042709) | Tyco Healthcare | 2005-01-18 |
| GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS (K042938) | Gambro Renal Products | 2005-01-06 |
| BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET (K033210) | Bioteque Corp. | 2004-12-30 |
| MODIFICATION TO: ZILVER 635 BILIARY STENT (K043481) | Cook, Inc. | 2004-12-29 |
| LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER (K043241) | Astra Tech, Inc. | 2004-12-23 |
| LIFESTENT NT35 BILIARY STENT SYSTEM (K042985) | Edwards Lifesciences, LLC | 2004-12-23 |
| PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP (K043272) | Kendall | 2004-12-22 |
| FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR (K043244) | Fresenius Medical Care North America | 2004-12-20 |
| MD-6W WIRELESS CRITICAL DATA VIEWER (K042923) | The Microoptical Corporation | 2004-12-17 |
| CORTRAK (K041987) | Viasys Medsystems | 2004-12-17 |
| THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (K040049) | STERIS Corporation | 2004-12-17 |
| MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 (K043258) | Teleflex Medical | 2004-12-16 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 (K043153) | Intuitive Surgical, Inc. | 2004-12-15 |
| KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE (K043114) | Kimberly-Clark Corp. | 2004-12-10 |
| PRIMUS STENT AND DELIVERY SYSTEM (K043243) | Ev3, Inc. | 2004-12-09 |
| STERICHEK BLOOD LEAK REAGENT STRIPS (K042322) | Hach Company | 2004-12-07 |
| BARD INLAYOPTIMA URETERAL STENT WITH SUTURE (K043193) | C.R. Bard, Inc. | 2004-12-07 |
| GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K042427) | Genemed, Inc. | 2004-12-03 |
| 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS (K042858) | Spire Biomedical, Inc. | 2004-12-03 |
| MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 (K043027) | Applied Medical Technology, Inc. | 2004-12-02 |
| GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO (K042960) | Given Imaging , Ltd. | 2004-11-24 |
| 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER (K040328) | Medcomp | 2004-11-24 |
| FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 (K042043) | Fujinon, Inc. | 2004-11-24 |
| NX STAGE WATER PURIFICATION SYSTEM (K042089) | Nxstage Medical, Inc. | 2004-11-24 |