| AQUA PURE DEIONIZER EXCHANGE SERVICE (K072158) | Staubach Barror Water Systems, Inc. | 2008-02-21 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER (K070947) | Intuitive Surgical, Inc. | 2008-02-14 |
| INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER (K072627) | Intuitive Surgical, Inc. | 2008-02-07 |
| SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (K062798) | Cordis Corp. | 2008-02-06 |
| PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY (K072908) | Gambro Renal Products | 2008-02-04 |
| PRISMAFLEX SYSTEM, VERSION 3.20 (K072093) | Gambro | 2008-02-01 |
| SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 (K071646) | Idev Technologies, Inc. | 2008-01-31 |
| PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER (K072538) | United Medical Systems, Inc. | 2008-01-30 |
| ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE (K073719) | Advanced Surgical Concepts | 2008-01-29 |
| DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (K073092) | Spire Biomedical, Inc. | 2008-01-29 |
| SOLCART B (K072760) | B. Braun Medizintechnologie GmbH | 2008-01-29 |
| SKATER BILIARY CATHETER (K073672) | Angiotech | 2008-01-24 |
| DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, (K073093) | Spire Biomedical, Inc. | 2008-01-22 |
| ENTERAL FEEDING SPIKE ADAPTER (K072652) | Cedic S.R.L. | 2008-01-18 |
| ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM (K071104) | Flier'S Quality Water Systems, Inc. | 2008-01-14 |
| NEOMED Enteral FEEDING TUBE (K072881) | Neomed, Inc. | 2008-01-09 |
| MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM (K072684) | Mondeal North America, Inc. | 2008-01-04 |
| LITHOSKOP (K070665) | Siemens Medical Solutions USA, Inc. | 2008-01-04 |
| STORZ MODULITH LITHOTRIPTER SLX-F2-F180 (K072788) | KARL STORZ Endoscopy-America, Inc. | 2007-12-26 |
| TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE (K073399) | Envisioneering, LLC | 2007-12-21 |
| AMSURE BLADDER IRRIGATION SET (K070873) | Amsino Intl., Inc. | 2007-12-19 |
| NEOMED URINARY CATHETER (K072997) | Neomed, Inc. | 2007-12-19 |
| NON-IV ADAPTER FOR INFANT NG TUBE (K072756) | Promedic, Inc. | 2007-12-19 |
| VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM (K072180) | Vision-Sciences, Inc. | 2007-12-18 |
| THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT (K072476) | Boston Scientific Corporation | 2007-12-14 |
| GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (K072594) | Gyrus Acmi, Inc. | 2007-12-13 |
| SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 (K072550) | Medevice, Inc. | 2007-12-07 |
| ONEPORT SURGICAL TROCAR SYSTEM (K073009) | Conmed Corporation | 2007-12-07 |
| BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS (K070558) | C.R. Bard, Inc. | 2007-12-07 |
| BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS (K070582) | C.R. Bard, Inc. | 2007-12-07 |
| GUIDEWIRE, MODEL G-V220-3527S AND OTHERS (K072354) | Accellent, Inc. | 2007-12-07 |
| R-PORT II LAPAROSCOPIC ACCESS DEVICE (K073170) | Advanced Surgical Concepts | 2007-12-03 |
| DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) (K071202) | Dermaport, Inc. | 2007-11-30 |
| HABIB ENDOBLATE (K072383) | Emcision , Ltd. | 2007-11-29 |
| COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (K072521) | Cook Urological, Inc. | 2007-11-20 |
| PEF TUBE (K071579) | N.M. Beale Co., Inc. | 2007-11-20 |
| SOPRO 225 DUAL HALOGEN LIGHT SOURCE (K072912) | Sopro | 2007-11-16 |
| RESOLVE BILIARY DRAINAGE CATHETER (K063733) | Merit Medical Systems, Inc. | 2007-11-14 |
| SPEEDICATH COMPACT (K072808) | Coloplast Corp. | 2007-11-09 |
| COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM (K062264) | Medtronic Vascular | 2007-11-08 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (K070643) | Gambro, Inc. | 2007-11-02 |
| MODULARIS VARIOSTAR (K070799) | Siemens Medical Solutions USA, Inc. | 2007-11-01 |
| GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 (K072787) | Syncro Medical Innovations, Inc. | 2007-10-31 |
| NOVOFLO CATHETER LT (K072499) | Novosci, Inc. | 2007-10-30 |
| REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 (K071764) | Obtech Medical Sarl | 2007-10-24 |
| CYBERWAND STERILE PADS, MODEL: CW-RBPBX (K072422) | Cybersonics, Inc. | 2007-10-24 |
| ONCONTROL BONE MARROW BIOPSY SYSTEM (K072045) | Vidacare Corporation | 2007-10-22 |
| REDSENSE (K071013) | Redsense Medical AB | 2007-10-18 |
| PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R (K071909) | Barkey GmbH & Co. KG | 2007-10-18 |
| ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT (K072125) | Ndo Surgical, Inc. | 2007-10-18 |
| LIGHT SABRE SPINAL ACCESS DEVICE (K071814) | Minrad, Inc. | 2007-10-16 |
| REALHAND HIGH DEXTERITY INSTRUMENTS (K072715) | Novare Surgical Systems, Inc. | 2007-10-16 |
| DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (K071049) | Tyco Healthcare | 2007-10-16 |
| REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K063788) | Ascent Healthcare Solutions | 2007-10-15 |
| GAMBRO CARTRIDGE BLOOD SETS (K070414) | Gambro Renal Products | 2007-10-12 |
| COLONIC & ENEMA NOZZLE (K071057) | Tiller Mind Body, Inc. | 2007-10-05 |
| KII TROCAR SYSTEM (K072674) | Applied Medical Resources Corp. | 2007-10-05 |
| NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 (K072024) | Nipro Medical Corp. | 2007-10-04 |
| REPROCESSED TROCARS (K070059) | Ascent Healthcare Solutions | 2007-10-02 |
| MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM (K061519) | NIKKISO CO., LTD. | 2007-09-28 |
| LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (K070881) | Sapimed S.P.A. | 2007-09-26 |
| MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (K071832) | Medical Scientific, Inc. | 2007-09-18 |
| ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR (K071553) | Ndo Surgical, Inc. | 2007-09-18 |
| EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES (K071651) | Endogastric Solutions, Inc. | 2007-09-14 |
| MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM (K063481) | Abbott Vascular, Inc. | 2007-09-14 |
| OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K063259) | Olympus Medical Systems Corporation | 2007-09-14 |
| USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (K072405) | Usgi Medical | 2007-09-13 |
| CURE CATHETER (K072539) | Cure Medical, LLC | 2007-09-13 |
| AQUADEX FLEXFLOW SYSTEM (K071854) | Chf Solutions, Inc. | 2007-09-07 |
| GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL (K072232) | Gambro Renal Products, Inc. | 2007-09-07 |
| NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE (K071145) | Nipro Medical Corporation | 2007-09-07 |
| NES REPROCESSED ENDOSCOPIC TROCAR (K060676) | Northeast Scientific, Inc. | 2007-09-07 |
| FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (K071167) | Medigroup, Inc. | 2007-08-31 |
| STORZ SLX-F2 STORM TOUCH (K070579) | KARL STORZ Endoscopy-America, Inc. | 2007-08-30 |
| NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 (K071263) | Nxstage Medical, Inc. | 2007-08-24 |
| R-PORT LAPAROSCOPIC ACCESS DEVICE (K070158) | Advanced Surgical Concepts | 2007-08-23 |
| 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET (K071422) | Rex Medical | 2007-08-22 |
| CONMED LINVATEC 300W XENON LIGHT SOURCE (K070376) | Conmed Linvatec | 2007-08-20 |
| URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 (K071822) | Uroplasty, Inc. | 2007-08-20 |
| DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS (K071518) | B. Braun Medizintechnologie GmbH | 2007-08-17 |
| ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE (K071756) | Pointe Conception Medical, Inc. | 2007-08-15 |
| INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER (K070151) | Ethicon Endo-Surgery, LLC | 2007-08-15 |
| ICATH, STERILESURE (K071496) | Colorado Catheter Company, Inc. | 2007-08-15 |
| NEOGUIDE ENDOSCOPY SYSTEM (K070622) | Neoguide Systems, Inc. | 2007-08-14 |
| MODIFICATION TO SOLAR GI (K071094) | Medical Measurement Systems B.V. | 2007-08-13 |
| SELF-LIGHT DISPOSABLE ANOSCOPE (K070913) | Sapimed S.P.A. | 2007-08-10 |
| HF JUNIOR HEMOFILTER (K071298) | Minntech Corp. | 2007-08-08 |
| SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM (K071571) | Surgiquest, Inc. | 2007-07-30 |
| D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW (K063355) | Novosci Corp. | 2007-07-27 |
| NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT (K071191) | Novartis Nutrition Corp. | 2007-07-23 |
| VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (K071292) | Richard Wolf Medical Instruments Corp. | 2007-07-19 |
| MEDLINE LATEX FOLEY CATHETER (K071423) | Medline Industries, Inc. | 2007-07-18 |
| SAPIMED DISPOSABLE SIGMOIDOSCOPE (K070915) | Sapimed S.P.A. | 2007-07-06 |
| FLEX-NECK ARC CATHETER (K070730) | Medigroup, Inc. | 2007-07-03 |
| SPYCATCH STONE RETRIEVAL BASKET (K071066) | Boston Scientific Corp | 2007-06-29 |
| REALHAND HIGH DEXTERITY (HD) INSTRUMENTS (K071488) | Novare Surgical Systems, Inc. | 2007-06-29 |
| ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (K070572) | Ash Access Technology, Inc. | 2007-06-26 |
| SKATER BILIARY CATHETER (K070610) | Angiotech | 2007-06-21 |
| FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB (K071387) | Fresenius Medical Care North America | 2007-06-15 |
| MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING (K063876) | Medivators Reprocessing Systems | 2007-06-14 |