| COLONIC & ENEMA NOZZLE (K071057) | Tiller Mind Body, Inc. | 2007-10-05 |
| ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL (K072699) | Alma Lasers , Ltd. | 2007-10-05 |
| ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (K072204) | Siemens Medical Solutions Diagnostics | 2007-10-05 |
| KII TROCAR SYSTEM (K072674) | Applied Medical Resources Corp. | 2007-10-05 |
| ZIPKNOT, MODEL 1017-3000 (K072525) | Medicinelodge, Inc. | 2007-10-05 |
| INTRACEPT BI-POLAR RF PROBE, MODEL 04814 (K070443) | Relievant Medsystems, Inc. | 2007-10-05 |
| PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS (K072572) | Lifecore Biomedical, Inc. | 2007-10-05 |
| ZIMMER DTO IMPLANT (K071879) | Zimmer Spine, Inc. | 2007-10-05 |
| VAX-D GENESIS G2 SYSTEM (K071347) | Vax-D Medical Technologies, LLC | 2007-10-05 |
| MODIFICATION TO OASYS SYSTEM (K072568) | Stryker Spine | 2007-10-05 |
| POWERPICC SOLO (K072230) | C.R. Bard, Inc. | 2007-10-05 |
| CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL (K071340) | Thermofisher Scientific OY | 2007-10-05 |
| SUCTION COAGULATOR (K072559) | Megadyne Medical Products, Inc. | 2007-10-05 |
| VCARE RETRACTOR/ELEVATOR (K071907) | Conmed Corporation | 2007-10-05 |
| MEDICAL MAGGOTS, CREATURE COMFORTS (K072438) | Monarch Labs, LLC | 2007-10-05 |
| MONOSWIFT (K072229) | Cp Medical | 2007-10-05 |
| SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS (K072233) | Leonhard Lang GmbH | 2007-10-05 |
| MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC (K072173) | Micrus Endovascular Corporation | 2007-10-05 |
| ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS (K071946) | Atlantis Components, Inc. | 2007-10-05 |
| PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G (K071511) | Focus Diagnostics, Inc. | 2007-10-05 |
| CSCS-001A CALCIUM SCORING PACKAGE (K072737) | Toshiba America Medical Systems, In.C | 2007-10-05 |
| MICRUS COURIER ENZO MICROCATHETER 0.0190 (K072526) | Micrus Endovascular Corporation | 2007-10-05 |
| HARMONY LED-1 SURGICAL LIGHTING SYSTEM (K072072) | STERIS Corporation | 2007-10-05 |
| ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM (K072543) | Lifescan, Inc. | 2007-10-05 |
| CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (K063131) | Thermo Electron OY | 2007-10-05 |
| ICU MEDICAL SINGLE-USE SYRINGE (K070856) | Icu Medical, Inc. | 2007-10-05 |
| PIONEER CATHETER (K072155) | Medtronic, Inc. | 2007-10-05 |
| POLYPERF / POLYPERF SAFE (K063631) | Laboratoires Perouse | 2007-10-05 |
| MODIFICATION TO SPACE CPSXL BONE CEMENT (K072496) | Dfine, Inc. | 2007-10-05 |
| ELECSYS CORTISOL TEST SYSTEM (K070788) | Roche Diagnostics | 2007-10-05 |
| SMALL BONE WEDGE (K070592) | Wrightmedicaltechnologyinc | 2007-10-05 |
| IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) (K070354) | International Medical Development, Inc. | 2007-10-05 |
| REFLECTION, TANDEM UNIPOLAR (K071160) | Smith & Nephew, Inc. | 2007-10-05 |
| Optima ZS Transition Screw (K071880) | Zimmer Spine, Inc. | 2007-10-05 |
| VHP 136 TRAY (K070769) | STERIS Corporation | 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 |
| TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 (K072589) | Zimmer Dental, Inc. | 2007-10-04 |
| POWRSYRINGE ASPIRATOR (K072299) | Pinyons Medical Technology, Inc. | 2007-10-04 |
| PNEUPAC VR1 AIR MIX (K071527) | Smiths Medical International , Ltd. | 2007-10-04 |
| ENDOWAVE INFUSION SYSTEM (K072507) | Ekos Corp. | 2007-10-04 |
| SCANVIEW, MODEL SC-300 (K071398) | Applied Spectral Imaging , Ltd. | 2007-10-04 |
| VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM (K062297) | STERIS Corporation | 2007-10-04 |
| ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS (K070798) | Coeur, Inc. | 2007-10-04 |
| PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K071421) | Promepla | 2007-10-04 |
| CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES (K071740) | Medtexx Manufacturing Sdn. Bhd. | 2007-10-04 |
| RADIUS SNARE (K070502) | Radius Medical Technologies, Inc. | 2007-10-04 |
| NIKO CORPECTOMY SPACER (K072465) | Globus Medical, Inc. | 2007-10-04 |
| CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 (K071681) | Beckman Coulter, Inc. | 2007-10-04 |
| ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F (K072039) | Taidoc Technology Corporation | 2007-10-03 |
| MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072512) | Datex-Ohmeda, Inc. | 2007-10-03 |
| SULTAN TOOTH ROOT DESENSITIZER (K072342) | Dentsply International, Inc. | 2007-10-03 |
| E3-80 PORTABLE ECG RECORDER & ANALYZER (K071085) | Micro-Star International Co., Ltd. | 2007-10-03 |
| NOVATOME, MODEL: SU101-50 (K072051) | Scholten Surgical Instruments, Inc. | 2007-10-03 |
| INOMAX DS (K071516) | Ino Therapeutics, LLC | 2007-10-03 |
| CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER (K072148) | Cook, Inc. | 2007-10-03 |
| SUNIRAY 5.2 (K072665) | Orangedental GmbH & Co. KG | 2007-10-03 |
| COOLTOUCH, MODEL LC215,COOLLIPO (K072424) | New Star Lasers, Inc. | 2007-10-03 |
| FORU, MODEL EQ30 (K072630) | Kwang Yang Motor Co., Ltd. | 2007-10-03 |
| BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER (K072008) | Braemar, Inc. | 2007-10-03 |
| VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM (K070296) | Ace Vision Group | 2007-10-03 |
| AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (K071580) | Thermofisher Scientific OY | 2007-10-03 |
| APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 (K071230) | Advanced Brain Monitoring, Inc. | 2007-10-03 |
| MODIFICATION TO BIOSTAR OIA SHIGATOX (K071799) | Iverness Medical Professional Diagnostics | 2007-10-02 |
| AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM (K072606) | Toshiba America Medical Systems, In.C | 2007-10-02 |
| HABIB VESEAL (K072126) | Emcision , Ltd. | 2007-10-02 |
| REPROCESSED TROCARS (K070059) | Ascent Healthcare Solutions | 2007-10-02 |
| ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT (K072624) | Astra Tech AB | 2007-10-01 |
| MONACO RTP SYSTEM (K071938) | Computerized Medical Systems, Inc. | 2007-10-01 |
| DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES (K071397) | Sunrise Medical | 2007-10-01 |
| GATECT-RT (K072171) | Vision RT Limited | 2007-10-01 |
| MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM (K072468) | Spectrum Dynamics , Ltd. | 2007-10-01 |
| SLEUTH IMPLANTABLE ECG MONITORING SYSTEM (K063035) | Transnoma Medical, Inc. | 2007-10-01 |
| AMSURE NEBULIZER (K070411) | Amsino International, Inc. | 2007-10-01 |
| LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 (K071480) | DiaSorin, Inc. | 2007-10-01 |
| DEPUY DELTA TS CERAMIC FEMORAL HEADS (K071830) | DePuy Orthopaedics, Inc. | 2007-09-28 |
| ARCHITECT SIROLIMUS ASSAY (K070822) | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| NEUTROPHASE WOUND CLEANSER (K071056) | Novabay Pharmaceuticals | 2007-09-28 |
| SPACER (K072069) | Vericom Co., Ltd. | 2007-09-28 |
| RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (K071845) | Acclarent, Inc. | 2007-09-28 |
| QXT EXTRACTION CATHETER (K071727) | Vascular Solutions, Inc. | 2007-09-28 |
| AUTOSUTURE ABSORBABLE TACK AND APPLICATOR (K071920) | United States Surgical, A Division of Tyco Healthc | 2007-09-28 |
| MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM (K061519) | NIKKISO CO., LTD. | 2007-09-28 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K072429) | Medtronic Sofamor Danek | 2007-09-28 |
| CA, MODEL: CAM (K071250) | Optovue, Inc. | 2007-09-28 |
| FITMATE SERIES (K071533) | Cosmed Srl | 2007-09-28 |
| BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 (K071578) | Lifescience Plus, Inc. | 2007-09-27 |
| SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS (K072095) | Synthes (Usa) | 2007-09-27 |
| MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (K072413) | Agamatrix | 2007-09-27 |
| RELIANCE VBS SYSTEM (K063637) | Reliance Medical Systems, LLC | 2007-09-27 |
| I45, I45S, I60, AND I60S (K071708) | Power Medical Interventions, Inc. | 2007-09-27 |
| PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K071800) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-09-27 |
| ENSEAL TISSUE SEALING DEVICE (K072493) | Surgrx, Inc. | 2007-09-27 |
| OMNIWAVE ENDOVASCULAR SYSTEM (K071762) | Omnisonics Medical Technologies | 2007-09-27 |
| LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (K063838) | Thermo Electron OY | 2007-09-27 |
| MIM 4.1 (SEASTAR) (K071964) | Mimvista Corp. | 2007-09-26 |
| ASAHI PTCA GUIDE WIRE, X-TREME (K072431) | Asahi Intecc Co., Ltd. | 2007-09-26 |
| BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 (K070156) | Cardiodynamics International Corp. | 2007-09-26 |
| P.004 NC ANATOMIC ABUTMENTS (K071357) | Institut Straumann AG | 2007-09-26 |
| ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 (K072517) | Boston Scientific Corp | 2007-09-26 |
| POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 (K072296) | Theragenics Corp. | 2007-09-26 |