| EUROIMMUN ANTI-CCP ELISA (K070789) | Euroimmun Us, LLC | 2007-12-31 |
| KENSEY NASH MACROPORE SHIELD (K071695) | Kensey Nash Corp. | 2007-12-31 |
| PENUMBRA SYSTEM (K072718) | Penumbra, Inc. | 2007-12-28 |
| NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM (K070857) | Nobel Biocare AB | 2007-12-28 |
| SCANSCOPE XT SYSTEM (K071671) | Aperio Technologies | 2007-12-28 |
| POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (K071905) | Lanx, LLC | 2007-12-28 |
| ADVANCE 18LP PTA DILATATION CATHETER (K073378) | Cook, Inc. | 2007-12-28 |
| ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES (K072528) | Prosurg, Inc. | 2007-12-28 |
| ALARIS SYSTEM WITH MMS, MODEL 8XXX (K072105) | Cardinal Health 303,Inc. | 2007-12-28 |
| OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET (K072937) | Olsen Medical | 2007-12-28 |
| NOBELACTIVE MULTI UNIT ABUTMENT (K072570) | Nobel Biocare AB | 2007-12-28 |
| EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) (K072813) | Phasein AB | 2007-12-28 |
| AEROSOL SYSTEM (K063716) | Amici, Inc. | 2007-12-28 |
| CADENCE II (K073221) | Edan Instruments, Inc. | 2007-12-28 |
| SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM (K073436) | Lutronic Corporation | 2007-12-28 |
| FLEXCATH STEERABLE SHEATH & DILATOR (K070357) | Cryocath Technologies, Inc. | 2007-12-28 |
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |
| CYNOSURE YAG FAMILY LASER (K072484) | Cynosure, Inc. | 2007-12-27 |
| REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM (K072996) | Respironics, Inc. | 2007-12-27 |
| HEMOSIL FIBRINOGEN-C (K073367) | Instrumentation Laboratory CO | 2007-12-27 |
| HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 (K073178) | R&D Systems, Inc. | 2007-12-27 |
| REHASTIM & REHAMOVE (K073237) | Hasomed GmbH | 2007-12-27 |
| CHOLESTRAK HDL CHOLESTEROL HOME TEST (K072836) | Accutech, LLC | 2007-12-27 |
| SELF SEAL STERILIZATION POUCH (K071886) | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2007-12-27 |
| POLYBONE (K070012) | Kyung Won Medical Co., Ltd. | 2007-12-27 |
| SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER (K072159) | El.En Electronic Engineering Spa | 2007-12-27 |
| LUCENT MAGNUM (K073348) | Spinal Elements, Inc. | 2007-12-26 |
| 308 DERMATOLOGICAL EXCIMER SYSTEM (K073066) | Quantel Medical, Inc. | 2007-12-26 |
| STORZ MODULITH LITHOTRIPTER SLX-F2-F180 (K072788) | KARL STORZ Endoscopy-America, Inc. | 2007-12-26 |
| SPIROBANK G (K072979) | Mir Medical Intl. Research Srl | 2007-12-26 |
| FINESSE SYSTEM (K072261) | Primaeva Medical, Inc. | 2007-12-26 |
| THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) (K072231) | Esm Technologies, LLC | 2007-12-26 |
| ORACLE SPACER, OPAL SPACER (K072791) | Synthes Spine | 2007-12-26 |
| BODYFORM THORACIC FIXATION SYSTEM (K072407) | Theken Spine, LLC | 2007-12-21 |
| BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS (K072068) | Bioartificial Gel Technologies (Bagtech), Inc. | 2007-12-21 |
| MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT (K072328) | Medtrade Products , Ltd. | 2007-12-21 |
| 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (K073199) | Brontes Technologies | 2007-12-21 |
| TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE (K073399) | Envisioneering, LLC | 2007-12-21 |
| MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) (K071375) | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-21 |
| BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) (K072475) | Etac Sverige AB | 2007-12-21 |
| IRISPEC,CA/CB/CC (K072640) | Iris Diagnostics | 2007-12-21 |
| DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (K072965) | Dade Behring, Inc. | 2007-12-21 |
| VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (K072138) | bioMerieux, Inc. | 2007-12-21 |
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T (K072886) | Medrad, Inc. | 2007-12-21 |
| IMAGECHECKER CT CAD SOFTWARE SYSTEM (K043617) | Hologic, Inc. | 2007-12-21 |
| GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) (K062580) | GE Healthcare | 2007-12-21 |
| PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM (K072784) | Taidoc Technology Corporation | 2007-12-21 |
| MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 (K070458) | Biomedical Diagnostics (Bmd) SA | 2007-12-21 |
| LIFE4C (K063304) | Numedis, Inc. | 2007-12-21 |
| CAPILLARYS URINE (PN 2012) (K070486) | Sebia, Inc. | 2007-12-21 |
| STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 (K071482) | Synergetics, Inc. | 2007-12-20 |
| MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) (K073397) | Microlife Corp. | 2007-12-20 |
| FLASHLITE REBEL* (K073518) | Discus Dental, Inc. | 2007-12-20 |
| BD GENEOHM STAPHSR ASSAY (K071026) | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007-12-20 |
| KLS MARTIN XTERNAL FIXATOR (K072764) | KLS Martin L.P. | 2007-12-20 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) (K073398) | Microlife Corp. | 2007-12-20 |
| CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES (K073304) | Cardica, Inc. | 2007-12-20 |
| CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) (K072518) | Crs Medical Diagnostics, Inc. | 2007-12-20 |
| VARICATH PERIPHERAL INFUSION CATHETER (K073400) | Veinrx, Inc. | 2007-12-20 |
| LINASYS (K071063) | Pathfinder Therapeutics, Inc. | 2007-12-20 |
| 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES (K072697) | 3t Medical Systems, LLC | 2007-12-20 |
| NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS (K072980) | Nobel Biocare AB | 2007-12-20 |
| JOURNEY UNICONDYLAR FEMORAL IMPLANT (K073175) | Smith & Nephew, Inc. | 2007-12-20 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K073193) | Shijiazhuang Prosperous Plastic Co., Ltd. | 2007-12-20 |
| T-QUEST SYSTEM (K073456) | Medx, Inc. | 2007-12-20 |
| MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (K073230) | Biotronik, Inc. | 2007-12-20 |
| BELMONT QUOLIS 5000 SERIES DENTAL UNIT (K072273) | Takara Belmont USA, Inc. | 2007-12-20 |
| PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 (K072599) | Diadexus, Inc. | 2007-12-20 |
| ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) (K071706) | Clinical Data, Inc. | 2007-12-20 |
| DEPUY LPS DISTAL FEMORAL COMPONENT (K063686) | DePuy Orthopaedics, Inc. | 2007-12-20 |
| MALIBU SPINAL SYSTEM (K072605) | Seaspine, Inc. | 2007-12-20 |
| BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G (K073127) | Shandong Weigao Group Medical Polymer Co., Ltd. | 2007-12-20 |
| MODEL 250CX SERIES MATERNAL/FETAL MONITOR (K072976) | GE Healthcare | 2007-12-20 |
| LEGION POROUS PRIMARY (K073325) | Smith & Nephew, Inc. | 2007-12-20 |
| MEDICAL DISPLAY, MD205MG (K073448) | Nec Display Solutions , Ltd. | 2007-12-20 |
| STUDIODOP VICORDER (K071730) | Skidmore Medical, Limited | 2007-12-20 |
| JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (K072631) | Idaho Technology, Inc. | 2007-12-20 |
| XIDF-100A/B1 IMAGE PROCESSOR (K073259) | Toshiba America Medical Systems, In.C | 2007-12-20 |
| ANTIMICROBIAL AND SINGLE-PATIENT CUFFS (K071885) | Philips Medical Systems | 2007-12-20 |
| BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642) | Biomet 3i, Inc. | 2007-12-20 |
| MICROFUSE BONE VOID FILLER (K071187) | Globus Medical, Inc. | 2007-12-20 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K071818) | St Jude Medical | 2007-12-20 |
| DENTIN DESENSITIZER AGENT (K073117) | Dentsply Intl., Inc. | 2007-12-19 |
| PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 (K072810) | Vascular Solutions, Inc. | 2007-12-19 |
| PF4 IGG (K071781) | Genetic Testing Institute | 2007-12-19 |
| ECLIPSE TREATMENT PLANNING SYSTEM (K073020) | Varian Medical Systems, Inc. | 2007-12-19 |
| NIO 5MP, MODEL MDNG-5121 (K073205) | Barcoview, Medical Imaging Systems | 2007-12-19 |
| PATIENT CONTOURED MESH-PEEK (PCM-P) (K072707) | KLS-Martin L.P. | 2007-12-19 |
| STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 (K072466) | Scican , Ltd. | 2007-12-19 |
| OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 (K072168) | Well-Life Healthcare Limited | 2007-12-19 |
| JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (K072547) | Idaho Technology, Inc. | 2007-12-19 |
| LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (K072961) | Sra Developments, Ltd. | 2007-12-19 |
| MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER (K073423) | C.R. Bard, Inc. | 2007-12-19 |
| BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD (K072478) | Baylis Medical Co., Inc. | 2007-12-19 |
| SCANORA 3D (K073350) | Soredex Palodex Group OY | 2007-12-19 |
| PERFORMAX TOTAL FACE MASK (K072592) | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-19 |
| PROPLATE (K073360) | Bio Protech, Inc. | 2007-12-19 |
| GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM (K073408) | Ge Medical Systems Ultrasound and Primary Care Dia | 2007-12-19 |
| AMSURE BLADDER IRRIGATION SET (K070873) | Amsino Intl., Inc. | 2007-12-19 |
| NEOMED URINARY CATHETER (K072997) | Neomed, Inc. | 2007-12-19 |