| MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. (K052168) | Medline Industries, Inc. | 2006-02-16 |
| HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 (K053512) | Baxter Healthcare Corp | 2006-02-16 |
| ADVANCED UROLOGICAL CATHETER (K053429) | Entracare, LLC | 2006-02-08 |
| AQUADEX FLEXFLOW SYSTEM (K060008) | Chf Solutions, Inc. | 2006-02-02 |
| TECHDEVICE GUIDEWIRE (K053028) | Techdevice Corporation | 2006-01-31 |
| HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR (K050952) | Minntech Corp. | 2006-01-31 |
| NAVIGATOR ENDOSCOPY SYSTEM (K052930) | Neoguide Systems, Inc. | 2006-01-31 |
| STRYKER SCOPE WARMER (K053311) | Stryker Endoscopy | 2006-01-27 |
| MODULAR TROCAR SYSTEM (K060096) | Applied Medical Resources Corp. | 2006-01-24 |
| SPECIMEN RETRIEVAL SYSTEM (K060051) | Applied Medical Resources Corp. | 2006-01-19 |
| RM3 RENAL PRESERVATION SYSTEM (K053169) | Waters Instruments, Inc. | 2006-01-17 |
| AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (K051031) | Ameriwater | 2006-01-06 |
| MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS (K053322) | Roei Medical Technologies, Ltd. | 2006-01-06 |
| GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (K053410) | Kendall | 2006-01-06 |
| E-Z-EM ENDOSCOPIC CO2 REGULATOR (K053008) | E-Z-Em, Inc. | 2005-12-27 |
| MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION (K053286) | Nxstage Medical, Inc. | 2005-12-22 |
| LIFESTENT FLEXSTART BILIARY STENT SYSTEM (K053404) | Edwards Lifesciences, LLC | 2005-12-21 |
| CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER (K052135) | Cybersonics, Inc. | 2005-12-20 |
| GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER (K053245) | Uresil, LLC | 2005-12-20 |
| SOLAR GI (K052338) | Medical Measurement Systems B.V. | 2005-12-15 |
| GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H (K051520) | Gambro Renal Products | 2005-12-09 |
| COOK FORMULA 418 BILIARY STENT SYSTEM (K052539) | Cook, Inc. | 2005-12-09 |
| SKYLARK URO PROBE (K053007) | Skylark Device & Systems Co., Ltd. | 2005-12-05 |
| GIVEN DIAGNOSTIC SYSTEM (K052184) | Given Imaging , Ltd. | 2005-12-01 |
| MEDCOMP SPLIT CATH II (K051280) | Medcomp | 2005-11-30 |
| SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM (K050209) | Smith & Nephew, Inc. | 2005-11-23 |
| MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES (K051620) | Better Water, Inc. | 2005-11-18 |
| RUBICOR MAGIC BREAST BIOPSY DEVICE (K053151) | Rubicor Medical, Inc. | 2005-11-18 |
| TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 (K052413) | Medtronic Vascular | 2005-11-17 |
| PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS (K051711) | Denver Biomedical, Inc. | 2005-11-15 |
| OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F (K051886) | Olympus Medical Systems Corporation | 2005-11-14 |
| B. BRAUN MODIFIED BICARBONATE DIALYSATE (K052393) | B.Braun Medical, Inc. | 2005-11-09 |
| PEDIATRIC FEEDING TUBE (K052903) | Promedic, Inc. | 2005-11-09 |
| AQUADEX SYSTEM (K050609) | Chf Solutions, Inc. | 2005-11-09 |
| ABBOTT SPINE, INC. SPINNAKER SYSTEM (K052638) | Abbott Spine, Inc. | 2005-11-07 |
| OZONE GENERATOR (K043207) | Ge Infrastructure Water & Process Technologies | 2005-11-04 |
| PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS (K052435) | Pneumrx, Inc. | 2005-11-03 |
| Y2K2 ENTERNAL TUBE FLUID FILTER (K051206) | Moss Medical Products | 2005-11-02 |
| MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS (K052253) | Gambro Renal Products | 2005-11-02 |
| MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE (K052802) | Manan Medical Products, Inc. | 2005-11-01 |
| DSNARE, MODEL 00711087 (K051637) | United States Endoscopy Group, Inc. | 2005-10-31 |
| HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM (K051276) | Richard Wolf Medical Instruments Corp. | 2005-10-28 |
| N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 (K043383) | Physion, Inc. | 2005-10-27 |
| URGENT PC NEUROMODULATION SYSTEM (K052025) | Uroplasty, Inc. | 2005-10-17 |
| NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM (K052740) | Conmed Integrated Systems (Cmis) | 2005-10-17 |
| EVIS EXERA 160A SYSTEM (K051645) | Olympus Medical Systems Corporation | 2005-10-13 |
| ENTERAL FEEDING TUBE (K051480) | Biosearch Medical Products, Inc. | 2005-10-12 |
| MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K052440) | Mentor Corporation | 2005-10-11 |
| COOK IRELAND ECHOBRUSH (K052279) | Cook Ireland, Ltd. | 2005-10-11 |
| INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (K051950) | Ethicon Endo-Surgery, Inc. | 2005-10-07 |
| 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (K051584) | Kendall | 2005-10-06 |
| FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 (K051176) | Richard Wolf Medical Instruments Corp. | 2005-10-05 |
| CYSTOGLIDE DILATING INTRODUCER SHEATH (K052134) | Percutaneous Systems, Inc. | 2005-09-22 |
| ENDO-EASE ENDOSCOPIC OVERTUBE (K052084) | Spirus Medical, Inc. | 2005-09-14 |
| ACCORDION (K052048) | Percutaneous Systems, Incorporated | 2005-09-13 |
| F-400 SYSTEM (K051585) | Mauna Kea Technologies | 2005-09-06 |
| UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (K051593) | Acmi Corporation | 2005-09-02 |
| ORS MODEL 6000 ENDOSCOPE HOLDER (K051979) | O.R. Solutions, Inc. | 2005-08-30 |
| UROPLASTY RIGID ENDOSCOPIC NEEDLE (K051905) | Uroplasty, Inc. | 2005-08-29 |
| BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP (K052114) | Bard Peripheral Vascular, Inc. | 2005-08-25 |
| SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (K052194) | Boston Scientific Corp | 2005-08-24 |
| MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM (K052132) | Edwards Lifesciences, LLC | 2005-08-24 |
| FORMULA 418 BILIARY STENT (K051785) | Cook, Inc. | 2005-08-23 |
| NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) (K050827) | Dialysis Solutions, Inc. | 2005-08-22 |
| COLONIC AND ENEMA NOZZLE (K051344) | Ultimate Concepts, Inc. | 2005-08-18 |
| ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (K052044) | Acmi Corporation | 2005-08-16 |
| MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 (K051613) | Olympus Medical Systems Corporation | 2005-08-15 |
| HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS (K051748) | C.R. Bard, Inc. | 2005-08-12 |
| ENDOSCOPIC APPLICATOR (K051732) | ETHICON, Inc. | 2005-08-09 |
| OMNI SPHINCTEROTOME (K052051) | Wilson-Cook Medical, Inc. | 2005-08-05 |
| JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET (K051814) | Jms North America Corp. | 2005-08-04 |
| HANS HERMANN LAPAROSCOPES AND ACCESSORIES (K051610) | Hans Hermann GmbH | 2005-07-29 |
| CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (K050808) | Cardio-Optics, Inc. | 2005-07-28 |
| SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 (K051581) | Sanarus Medical, Inc. | 2005-07-27 |
| MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY (K051506) | Sterylab S.R.L. | 2005-07-27 |
| MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE (K051919) | Usgi Medical | 2005-07-26 |
| REPROCESSED COLD BIOPSY FORCEPS (K042648) | Sterilmed, Inc. | 2005-07-20 |
| REPROCESSED HOT BIOPSY FORCEPS (K050136) | Sterilmed, Inc. | 2005-07-20 |
| CONMED IRRIGATION NOZZLE (K050992) | Conmedcorp | 2005-07-14 |
| K-C HEMOSTATIC BIOPSY SYSTEM (K050135) | Bioengineering Consultants , Ltd. | 2005-07-13 |
| ZILVER 635 BILIARY STENT (K051124) | Cook, Inc. | 2005-07-12 |
| ZUTRON COLONOSCOPE STIFFENING DEVICE (K051068) | Zutron Medical | 2005-07-11 |
| SINGLE USE BALLOON DILATOR MAXPASSTM (K050502) | Olympus Winter & Ibe GmbH | 2005-07-08 |
| GF-UE160-AL5 ULTRASOUND ENDOSCOPE (K051541) | Olympus America, Inc. | 2005-07-01 |
| MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K050802) | Intuitive Surgical, Inc. | 2005-06-29 |
| AMSURE 100% SILICONE FOLEY CATHETER (K051059) | Amsino International, Inc. | 2005-06-28 |
| SMALL INTESTINAL VIDEOSCOPE SYSTEM (K051551) | Olympus Medical Systems Corporation | 2005-06-28 |
| NXSTAGE SYSTEM ONE (K050525) | Nxstage Medical, Inc. | 2005-06-24 |
| MANZI CLEANER SYSTEM (K043314) | Langford IC Systems, Inc. | 2005-06-20 |
| PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT (K051379) | Ev3 Corporation | 2005-06-17 |
| SPYSCOPE ACCESS AND DELIVERY CATHETER (K051504) | Boston Scientific Corp | 2005-06-16 |
| SONOTIP II ULTRASOUND NEEDLE SYSTEM (K051247) | Medi-Globe Corp. | 2005-06-16 |
| ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS (K050910) | Roei Medical Technologies, Ltd. | 2005-06-16 |
| EASY CORE DETACHABLE BIOPSY SYSTEM (K051361) | Boston Scientific Corp | 2005-06-16 |
| SERIM DIALYSATE MONITOR TEST STRIP (K043031) | Serim Research Corp. | 2005-06-13 |
| MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS (K050727) | Nxstage Medical, Inc. | 2005-06-13 |
| OLPUR DIALYZER, MODEL HD 190 (K050603) | Nephros, Inc. | 2005-06-09 |
| REXEED SERIES DIALYZERS (K051187) | Asahi Kasei Medical Co., Ltd. | 2005-06-08 |
| MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K050008) | Mentor Corp. | 2005-06-03 |
| ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (K043574) | Renal Solutions, Inc. | 2005-06-03 |