| MITAKA UNIARM (K090792) | Mitaka Kohki Co., Ltd. | 2009-07-06 |
| DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) (K090851) | Byrne Medical, Inc. | 2009-07-02 |
| UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 (K091391) | Uroplasty, Inc. | 2009-06-30 |
| NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER (K090885) | Nephros, Inc. | 2009-06-29 |
| HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (K090980) | Olympus Winter & Ibe GmbH | 2009-06-29 |
| ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 (K090583) | Apollo Endosurgery, Inc. | 2009-06-26 |
| ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 (K083685) | Mri Manufacturing and Research, Inc. | 2009-06-25 |
| COSTORSOL (K091245) | Preservation Solutions, Inc. | 2009-06-17 |
| FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES (K091490) | Thd Spa | 2009-06-11 |
| HABIB ENDOHPB (K083292) | Emcision , Ltd. | 2009-06-10 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K083275) | Max Endoscopy, Inc. | 2009-06-09 |
| THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 (K091340) | Boston Scientific Corp | 2009-06-09 |
| EXALIS, SOFTWARE VERSION 1.15 (K083158) | Gambro, Inc. | 2009-06-05 |
| REVOLUTION FULL CORE BIOPSY (K090611) | Inrad | 2009-06-04 |
| BACKSTOP AND BACKSTOP INJECTOR (K090430) | Pluromed, Inc. | 2009-06-02 |
| KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION (K083598) | KARL STORZ Endoscopy-America, Inc. | 2009-05-29 |
| HEMORPEX SYSTEM (K090432) | Angiologica B. M. Srl | 2009-05-29 |
| DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT (K090528) | C.R. Bard, Inc. | 2009-05-28 |
| PERCUCATH URINARY CATHETER (K090262) | Percuvision, LLC | 2009-05-28 |
| DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES (K090979) | Encision, Inc. | 2009-05-28 |
| BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 (K082589) | Barosense, Inc. | 2009-05-22 |
| SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A (K091417) | Terumo Corp. | 2009-05-22 |
| FREEHAND (K090340) | Prosurgics Limited | 2009-05-22 |
| EG-3870UTK (K090197) | Pentax Medical Company | 2009-05-19 |
| MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM (K091070) | Sierra Scientific Instruments, Inc. | 2009-05-19 |
| EG-3670URK (K090196) | Pentax Medical Company | 2009-05-19 |
| VS-100 ILLUMINATION AND IMAGING SYSTEM (K090800) | Schoelly Imaging, Inc. | 2009-05-18 |
| BACKSTOP CATHETER, MODEL 60-0000-3100 (K090270) | Pluromed, Inc. | 2009-05-15 |
| AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES (K090470) | Covidien | 2009-05-14 |
| FSC 2 (K090601) | Schoelly Imaging, Inc. | 2009-05-11 |
| ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE (K090338) | Reprocessing Products Corp | 2009-05-08 |
| MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM (K091257) | Medi-Globe Corporation | 2009-05-08 |
| INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT (K082497) | Intuitive Surgical, Inc. | 2009-05-07 |
| INNOPORT LAPAROSCOPIC ACCESS DEVICE (K090677) | Innovia, LLC | 2009-05-07 |
| FOOTPRINT MEDICAL SILICONE FEEDING TUBE (K090559) | Footprint Medical | 2009-05-04 |
| BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 (K090217) | Coloplast A/S | 2009-04-23 |
| WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM (K083374) | Boston Scientific Corp | 2009-04-22 |
| FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 (K090116) | Fujinon, Inc. | 2009-04-22 |
| MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K090814) | Gyrus Acmi, Inc. | 2009-04-20 |
| PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS (K090631) | PAJUNK GmbH Medizintechnologie | 2009-04-16 |
| PRE-FILLED CATHETER INFLATION SYRINGE (K090121) | Avail Medical Products, Inc. | 2009-04-15 |
| PROGUIDE CHRONIC DIALYSIS CATHETER (K090148) | Merit Medical Systems, Inc. | 2009-04-13 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K090663) | American Medical Systems, Inc. | 2009-04-09 |
| WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 (K083627) | Boston Scientific Corporation | 2009-04-07 |
| SOPRO 184 CAMERA (K082796) | Sopro | 2009-04-01 |
| NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P (K082719) | NIKKISO CO., LTD. | 2009-03-30 |
| SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 (K083802) | Medi-Globe Corporation | 2009-03-20 |
| POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER (K083675) | C.R. Bard, Inc. | 2009-03-19 |
| STONE GRASPING BASKET, MODEL PD-T1 2115 (K082735) | Sialo Technology, Ltd. | 2009-03-13 |
| HEMOBAND, MODELS HB-NS AND HB-NSXL (K081740) | Innovations For Access, Inc. | 2009-03-12 |
| SILS STITCH ENDOSCOPIC SUTURING DEVICE (K090419) | Covidien Lp, Formerly Registered AS United States | 2009-03-09 |
| TC ENDO PORT (K083218) | Transcardiac Therapeutics, Inc. | 2009-03-06 |
| CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (K083776) | Corpak Medsystems | 2009-03-05 |
| CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S (K083791) | Corpak Medsystems | 2009-03-04 |
| ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (K083788) | Endooptiks, Inc. | 2009-03-03 |
| XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 (K083778) | Baxter Healthcare Corporation | 2009-02-20 |
| CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB (K083786) | Corpak Medsystems | 2009-02-20 |
| CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS (K090133) | Cook, Inc. | 2009-02-20 |
| MODIFICATION TO AUTO-BAND LIGATOR (K083556) | Scandimed International | 2009-02-19 |
| GELPORT SINGLE INCISION ACCESS SYSTEM (K090275) | Applied Medical Resources Corp. | 2009-02-18 |
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |
| MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT (K082988) | Medivators Reprocessing Systems | 2009-02-13 |
| NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS (K090102) | C.R. Bard, Inc. | 2009-02-12 |
| THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K083180) | Avantis Medical Systems, Inc. | 2009-02-12 |
| EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS (K090101) | C.R. Bard, Inc. | 2009-02-10 |
| BLOOD TUBING SETS (STERILE FLUID PATH) (K090255) | Nxstage Medical, Inc. | 2009-02-10 |
| ECHOTIP ULTRA ULTRASOUND NEEDLE (K083330) | Cook Endoscopy | 2009-02-06 |
| SMART DILATOR (K082995) | Safestitch Medical | 2009-02-06 |
| ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX (K083684) | Manufacturing & Research, Inc. | 2009-02-05 |
| ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (K083153) | Hollister, Inc. | 2009-02-04 |
| SPYSCOPE ACCESS AND DELIVERY CATHETER (K090170) | Boston Scientific Corp | 2009-02-04 |
| DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS (K082400) | Culligan Soft Water Service Co. | 2009-02-03 |
| SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET (K082710) | Neochild, LLC | 2009-01-23 |
| A.V. FISTULA BLUNT NEEDLE SET (K082882) | Jms North America Corp. | 2009-01-21 |
| COSTORSOL (K083453) | Preservation Solutions, Inc. | 2009-01-21 |
| VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 (K083194) | Terumo Cardiovascular Systems Corp. | 2009-01-16 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |
| HD CAMERA HEAD OTV-S7PROH-HD-L08E (K083155) | Olympus Medical Systems Corporation | 2009-01-13 |
| DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) (K082863) | Dynarex Corporation | 2009-01-09 |
| MEDINOL X-SUIT NIR BILIARY METALLIC STENT (K081956) | Medinol, Ltd. | 2009-01-09 |
| A-LAP SET (A-LAP, EZAXESS, TROCAR) (K082291) | Ezsurgical | 2009-01-02 |
| FRESENIUS STERILE STAY SAFE CAP (K083542) | Fresenius Medical Care North America | 2008-12-29 |
| CORFLO ANTI IV ENTERAL FEEDING TUBE (K083210) | Corpak Medsystems | 2008-12-29 |
| TORNADO ROTATABEL SNARE AND POLYP CATCHER (K083049) | Horizons Intl. Corp. | 2008-12-23 |
| FIXATION TROCARS (K083638) | Applied Medical Resources Corp. | 2008-12-23 |
| PRISMAFLO II (K082758) | Stihler Electronic GmbH | 2008-12-19 |
| STRYKER LED LIGHTSOURCE (K082813) | Stryker Corp. | 2008-12-19 |
| ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 (K082114) | Apollo Endosurgery, Inc. | 2008-12-19 |
| INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE (K081207) | Intuitive Surgical, Inc. | 2008-12-19 |
| URONIRS, MODEL 2000 (K082701) | Urodynamix Technologies, Ltd. | 2008-12-18 |
| XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (K082925) | KARL STORZ Endoscopy-America, Inc. | 2008-12-18 |
| VIKY (K082233) | Endocontrol | 2008-12-18 |
| AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM (K083211) | Surgiquest, Inc. | 2008-12-15 |
| FROG (K072831) | Newby-Coombs, LLC | 2008-12-12 |
| LUBRICANO STERILE GEL (K081990) | Farco Pharma GmbH | 2008-12-05 |
| 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT (K081739) | Boston Scientific Corp | 2008-12-03 |
| OMNI-DL SYSTEM (K080650) | Transvivo, Inc. | 2008-11-26 |
| ENTERAL ONLY EXTENSION SET (K082654) | Respironics, Inc. | 2008-11-25 |
| NITI-S BILIARY STENT (K073667) | Taewoong Medical Co., Ltd. | 2008-11-19 |
| SH14 HEMOCONCENTRATOR (K081313) | Sorin Group Italia S.R.L. | 2008-11-19 |