| AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS (K082322) | Covidien | 2008-11-14 |
| EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR (K082392) | Advanced Sterilization Products | 2008-11-13 |
| COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (K082803) | Percutaneous Systems, Inc. | 2008-11-13 |
| ENTERAL PUMP SET, MODEL 20-1010 (K081725) | Viasys Medsystems | 2008-11-07 |
| ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (K082056) | Life-Tech, Inc. | 2008-11-07 |
| SILS PORT, MODELS SILSPT5, SILSPT12 (K082619) | Covidien Lp, Formerly Registered AS United States | 2008-11-07 |
| CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 (K080613) | Minimally Invasive Devices, LLC | 2008-11-06 |
| OLYMPUS CHF TYPE V (K081456) | Olympus Medical Systems Corporation | 2008-11-06 |
| THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 (K082241) | Dale Medical Products, Inc. | 2008-10-30 |
| OPTIFLUX F250NR, MODEL 0500325E (K082414) | Fresenius Medical Care North America | 2008-10-28 |
| 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 (K081733) | Boston Scientific Corp | 2008-10-27 |
| PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 (K082464) | Medtronic, Inc. | 2008-10-27 |
| UC-CARE POSITIONING SYSTEM (K082919) | Uc-Care Medical Systems, Ltd. | 2008-10-27 |
| COOK WIRE GUIDES (K082536) | Cook Urological, Inc. | 2008-10-27 |
| AMSELF CLOSED CATHETERIZATION SYSTEM (K082831) | Amsino International, Inc. | 2008-10-23 |
| XCHF-T160 VIDEOSCOPE (K082576) | Olympus Medical Systems Corporation | 2008-10-21 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K082006) | American Medical Systems, Inc. | 2008-10-20 |
| NXSTAGE PUREFLOW SL (K080919) | Nxstage Medical, Inc. | 2008-10-15 |
| VACORA VACUUM ASSISTED BIOPSY SYSTEM (K082681) | C.R. Bard, Inc. | 2008-10-15 |
| KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO (K082046) | KARL STORZ Endoscopy-America, Inc. | 2008-10-10 |
| PERFADEX WITH THAM (K081997) | Vitrolife Sweden AB | 2008-10-09 |
| WELL LEAD SILICONE AND LATEX FOLEY CATHETERS (K082815) | Well Lead Medical Instruments | 2008-10-08 |
| ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX (K082515) | Asahi Kasei Medical Co., Ltd. | 2008-10-03 |
| STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) (K081995) | Stryker Endoscopy | 2008-10-02 |
| NEOMED POLYURETHANE FEEDING TUBE (K082238) | Neomed, Inc. | 2008-10-01 |
| INJEKT FILIFORM INJECTION NEEDLE (K082319) | Cook Urological, Inc. | 2008-09-25 |
| MODIFIED ENDO STICH (K082659) | Covidien Lp, Formerly Registered AS United States | 2008-09-19 |
| KEGEL8 PELVIC EXERCISER, MODEL OPH 400 (K081480) | Ne Services , Ltd. | 2008-09-12 |
| ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 (K082156) | Teleflex Medical | 2008-09-10 |
| TAXI ENDOSCOPIC GUIDEWIRE (K081708) | Lake Region Mfg., Inc. | 2008-08-26 |
| OVERSTITCH ENDOSCOPIC SUTURE SYSTEM (K081853) | Apollo Endosurgery, Inc. | 2008-08-18 |
| ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM (K072708) | Abbott Vascular-Vascular Solutions | 2008-08-18 |
| IEC MEDSIGHT AND MEDBRIGHT (K080809) | Innovative Endoscopy Components, LLC | 2008-08-11 |
| MAPERSOL (K080432) | Preservation Solutions, Inc. | 2008-08-08 |
| FOSSA URETERAL OPEN STENTS (K072293) | Fossa Medical, Inc. | 2008-08-06 |
| MODIFICATION TO ZILVER 635 BILIARY STENT (K080037) | Cook, Inc. | 2008-08-01 |
| DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 (K073112) | Intuitive Surgical, Inc. | 2008-08-01 |
| ANCHORAGE SCOPE, MODEL 000003 (K080780) | Epitek, Inc. | 2008-07-30 |
| BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 (K081323) | B-K Medical Aps | 2008-07-22 |
| GORE VIABIL BILILARY ENDOPROSTHESIS (K081184) | W.L. Gore & Associates, Inc. Medical Products Div. | 2008-07-22 |
| ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (K080067) | Iscience Interventional | 2008-07-18 |
| ASPIRA PERITONEAL DRAINAGE SYSTEM (K081288) | C.R. Bard, Inc. | 2008-07-18 |
| BLOOD TUBING SETS (STERILE FLUID PATH) (K080807) | Nxstage Medical, Inc. | 2008-07-18 |
| MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) (K080878) | Medical Technologies of Georgia, Inc. | 2008-07-17 |
| LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT (K081043) | Nxstage Medical, Inc. | 2008-07-07 |
| COSTORSOL (K073693) | Preservation Solutions, Inc. | 2008-07-03 |
| MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K080679) | Viasys Medsystems | 2008-06-27 |
| ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES (K073644) | Endogastric Solutions, Inc. | 2008-06-27 |
| ENDOSCOPY VIDEO CAMERA SYSTEM (K081585) | Vision Systems Group, A Division of Viking Systems | 2008-06-20 |
| LUXTEC MLX LIGHT SOURCE (K081477) | Integra Luxtec, Inc. | 2008-06-18 |
| INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL (K081057) | Intact Medical Corporation | 2008-06-17 |
| PRISMAFLEX M150 SET (K080519) | Gambro Renal Products, Inc. | 2008-06-13 |
| BARD DIGNICARE STOOL MANAGEMENT SYSTEM (K073598) | C.R. Bard, Inc. | 2008-06-13 |
| ETHICON ENDO SURGERY ARTICULATING SNARE (K073288) | Ethicon Endo-Surgery, Inc. | 2008-06-12 |
| CURE CATHETER CLOSED SYSTEM (K080881) | Cure Medical, LLC | 2008-06-11 |
| MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 (K080550) | Minos Medical | 2008-06-10 |
| BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK (K080703) | 4m Ventures, Inc. | 2008-06-02 |
| BARD E LUMINEXX BILIARY STENT (K063532) | Bard Peripheral Vascular, Inc. | 2008-05-30 |
| PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR (K080161) | Patton Surgical Corp. | 2008-05-29 |
| AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR (K081169) | Covidien Lp, Formerly Registered AS United States | 2008-05-23 |
| MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS (K080257) | Medtronic Xomed, Inc. | 2008-05-22 |
| XTJF TYPE Q160VF1 (K080403) | Olympus Medical Systems Corporation | 2008-05-20 |
| CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX (K080946) | Conmed Endoscopic Technologies, Inc. | 2008-05-20 |
| AUTO-BAND LIGATOR (K081142) | Scandimed International | 2008-05-16 |
| MPS ACACIA ENTERAL FEEDING TUBE (K080328) | Mps Acacia | 2008-05-14 |
| 3 CCD ENDOCAM 5550 (K080977) | Richard Wolf Medical Instruments Corp. | 2008-05-14 |
| SIALO BALLOON DILATATION CATHETER (K072749) | Sialo Technology, Ltd. | 2008-05-14 |
| GRADUATED ADAPTER WITH CLAVE (K080007) | Icu Medical, Inc. | 2008-05-13 |
| ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT (K080400) | AngioDynamics, Inc. | 2008-05-13 |
| PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY (K080654) | PAJUNK GmbH Medizintechnologie | 2008-05-08 |
| SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (K080712) | Serim Research Corp. | 2008-05-06 |
| OLYMPUS XCHF TYPE B180Y1 (K080586) | Olympus Medical Systems Corporation | 2008-05-06 |
| SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 (K080764) | Max Endoscopy, Inc. | 2008-05-06 |
| SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE (K080050) | Spirus Medical, Inc. | 2008-05-06 |
| PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL (K081004) | Stryker GI | 2008-05-02 |
| ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL (K080317) | Syntheon, LLC | 2008-04-29 |
| MARIONETTE SA, MODEL 001 001 & 001 002 (K072811) | Kinetic Surgical, LLC | 2008-04-21 |
| DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE (K072613) | Micro Invasive Technology, Inc. | 2008-04-21 |
| ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM (K072720) | Alveolus, Inc. | 2008-04-11 |
| CORAMATE/SPIROTOME SYSTEM (K080095) | Medinvents | 2008-04-11 |
| THD DISPOSABLE ANOSCOPE/PROCTOSCOPE (K080132) | Thd Spa | 2008-04-09 |
| KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 (K080410) | KARL STORZ Endoscopy-America, Inc. | 2008-04-09 |
| PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE (K073671) | Ndo Surgical, Inc. | 2008-03-26 |
| SMALL INTESTINAL VIDEOSCOPE SYSTEM (K071254) | Olympus Medical Systems Corporation | 2008-03-25 |
| VIRTUAL PORTS ENDOCLEAR SYSTEM (K080051) | Virtual Ports, Ltd. | 2008-03-21 |
| MANDREL GUIDEWIRES OR M-WIRE (K080508) | Lake Region Medical | 2008-03-21 |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER (K080291) | Intuitive Surgical, Inc. | 2008-03-19 |
| MEDLINE GASTROSTOMY TUBE (K073718) | Medline Industries, Inc. | 2008-03-19 |
| 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 (K072301) | Ev3, Inc. | 2008-03-18 |
| EVIS EXERA II 180 SYSTEM (K072957) | Olympus Medical Systems Corporation | 2008-03-18 |
| AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) (K073034) | Applied Medical Technology, Inc. | 2008-03-14 |
| ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 (K073484) | Ethicon Endo-Surgery, Inc. | 2008-03-10 |
| MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM (K080155) | Intuitive Surgical, Inc. | 2008-03-06 |
| SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 (K080171) | Sanarus Medical, Inc. | 2008-03-06 |
| COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG (K080340) | Novartis Nutrition Corp. | 2008-03-05 |
| LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (K073552) | Laborie Medical Technologies, Corp. | 2008-03-05 |
| VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM (K073279) | Visionsense, Ltd. | 2008-03-05 |
| ANCHORAGE ACCESS KIT (K073507) | Epitek, Inc. | 2008-03-05 |
| KIMBERLY-CLARK INTRODUCER KITS (K080253) | Kimberly-Clark Corp. | 2008-02-26 |
| NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (K072988) | Nipro Medical Corporation | 2008-02-21 |