| IDEAL SOFTWARE OPTION FOR GE MR SCANNERS (K072998) | Ge Medical Systems, LLC | 2007-11-01 |
| TITANIUM POWERPORT ISP IMPLANTED PORT (K072215) | C.R. Bard, Inc. | 2007-11-01 |
| THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS (K070984) | Abbott Diabetes Care, Inc. | 2007-11-01 |
| WIM-PC, MODEL 1010 (K071955) | Karmelsonix | 2007-11-01 |
| GRIPPER MICRO NEEDLE (K072059) | Smiths Medical MD, Inc. | 2007-11-01 |
| CSNP-001A NEURO PACKAGE (K072693) | Toshiba America Medical Systems, In.C | 2007-11-01 |
| MODULARIS VARIOSTAR (K070799) | Siemens Medical Solutions USA, Inc. | 2007-11-01 |
| PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM (K071416) | Medtronic Sofamor Danek USA, Inc. | 2007-11-01 |
| GALTSTICK INTRODUCER SYSTEM (K071330) | Galt Medical Corp. | 2007-10-31 |
| ERBE ERBEJET 2 SYSTEM (K072404) | Erbe USA, Inc. | 2007-10-31 |
| COMFORT POWERED WHEELCHAIR, LY-EB 206 (K072711) | Comfort Orthopedic Co., Ltd. | 2007-10-31 |
| METOXIT CAM-BLANKS (K072569) | Metoxit AG | 2007-10-31 |
| GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 (K072787) | Syncro Medical Innovations, Inc. | 2007-10-31 |
| Z-800 VOLUMETRIC INFUSION PUMP (K071545) | Zyno Medical, LLC | 2007-10-31 |
| CYTOPLAST PTFE SUTURE (K072076) | Osteogenics Biomedical, Inc. | 2007-10-31 |
| 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL (K072909) | Siemens AG Medical Solutions | 2007-10-31 |
| GAME READY CLASSIC SYSTEM, MODEL 550550 (K072620) | Coolsystems, Inc. | 2007-10-31 |
| COMFORT ELECTRIC SCOOTER, LY-EW408 (K072712) | Comfort Orthopedic Co., Ltd. | 2007-10-31 |
| BIOPLEX VASCULITIS KIT (K072358) | Bio-Rad Laboratories | 2007-10-31 |
| GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID (K072990) | Medtronic, Inc. | 2007-10-31 |
| PTFE PEEL AWAY MICROINTRODUCER (K072130) | Intromed | 2007-10-31 |
| SPEEDER 1.5T WRIST ARRAY COIL (K072935) | Quality Electrodynamics | 2007-10-31 |
| BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 (K072097) | Medical Select, Inc. | 2007-10-30 |
| SYMBIA-E, MODEL 10275879 (K072567) | Siemens Medical Solutions USA, Inc. | 2007-10-30 |
| NOVOFLO CATHETER LT (K072499) | Novosci, Inc. | 2007-10-30 |
| LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (K070315) | Lina Medical Aps | 2007-10-30 |
| MC 3003G-32R HEAD COIL (K072931) | Mr Instruments, Inc. | 2007-10-30 |
| FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 (K072557) | Faxitron X-Ray Corp. | 2007-10-30 |
| TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS (K071445) | Escada International, Inc. | 2007-10-29 |
| NEUROVISION JJB SYSTEM (K072343) | Nuvasive, Inc. | 2007-10-29 |
| APACERAM BONE GRAFT SUBSTITUTE (K071912) | Pentax Corp. | 2007-10-29 |
| BIOPRO MEMORY STAPLE, MODELS 18062-18073 (K072298) | Biopro, Inc. | 2007-10-29 |
| MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 (K072918) | Toshibamedical Systems Corporation | 2007-10-29 |
| D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR (K072091) | Sorin Group Italia S.R.L. | 2007-10-29 |
| Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX (K062542) | Z-Systems AG | 2007-10-29 |
| VALEO CERVICAL PLATE SYSTEM (K071990) | Amedica Corp. | 2007-10-29 |
| EXACTRAC 5.5 (K072506) | Brainlab AG | 2007-10-26 |
| INRATIO 2 PT MONITORING SYSTEM (K072727) | Hemosense, Inc. | 2007-10-26 |
| CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 (K071493) | Taidoc Technology Corporation | 2007-10-26 |
| STIMLAB (K072200) | Micropace Pty, Ltd. | 2007-10-26 |
| EXCELARREST FOAM (K072900) | Hemostasis, LLC | 2007-10-26 |
| ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 (K072545) | Pentron Clinical Technologies | 2007-10-26 |
| RNK ELECTRONIC STETHOSCOPE (K072026) | Rnk Products, Inc. | 2007-10-26 |
| TRACKPORT (K072529) | Direx Systems Corp. | 2007-10-26 |
| TROJAN-ENZ BRAND (K071313) | Church & Dwight Co., Inc. | 2007-10-26 |
| BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) (K071981) | Bonart Co., Ltd. | 2007-10-26 |
| INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM (K072086) | D B Orthodontics, Ltd. | 2007-10-26 |
| KFX TISSUE FIXATION SYSTEM AND ACCESSORIES (K072063) | Kfx Medical | 2007-10-26 |
| ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612) | Beckman Coulter, Inc. | 2007-10-26 |
| GENTLERAY 980 DIODE LASER SYSTEM (K072262) | Kavo America | 2007-10-26 |
| BEMITT, MODEL 0001 (K071787) | Dja Distributors, LLC | 2007-10-26 |
| SYSTEM-MINI, MODELS: 390, E30 (K072294) | Bio-Medical Research, Ltd. | 2007-10-25 |
| DRYSTAR AXYS, MODEL EYZ4E (K072680) | Agfa Healthcare Corporation | 2007-10-25 |
| GENERAL SEMEN ANALYSIS KIT (K071737) | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |
| DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) (K071904) | Carleton Life Support Systems, Inc. | 2007-10-25 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K072800) | Cardiovascular Systems, Inc. | 2007-10-25 |
| CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM (K072191) | Gvi Technology Partners | 2007-10-25 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED (K072472) | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-25 |
| HEMOCUE WBC SYSTEM (K071652) | Hemocue AB | 2007-10-25 |
| HEXAPOD EVO RT COUCH TOP (K072898) | Medical Intelligence Medizintechnik GmbH | 2007-10-25 |
| SMALL FRAGMENT LOCKING PLATING SYSTEM (K072083) | DePuy Orthopaedics, Inc. | 2007-10-25 |
| REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 (K071764) | Obtech Medical Sarl | 2007-10-24 |
| ESTECH PERCUTANEOUS INSERTION DILATOR KIT (K070749) | Coombs Medical Device Consulting | 2007-10-24 |
| ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM (K072081) | Alphatec Spine, Inc. | 2007-10-24 |
| DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 (K070265) | Diagnostic Hybrids, Inc. | 2007-10-24 |
| CYBERWAND STERILE PADS, MODEL: CW-RBPBX (K072422) | Cybersonics, Inc. | 2007-10-24 |
| CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON (K072327) | Regeneration Technologies, Inc. | 2007-10-24 |
| MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL (K072706) | Conmed Linvatec | 2007-10-24 |
| APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM (K072826) | Toshiba America Medical Systems, In.C | 2007-10-24 |
| ZUMA (K071726) | Seaspine, Inc. | 2007-10-23 |
| MODIFICATON TO: ARTHROCARE ARTHROWANDS (K072865) | Arthrocare Corp. | 2007-10-23 |
| PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) (K070520) | Biolife, LLC | 2007-10-23 |
| BIOMET CABLE SYSTEM (K071271) | Biomet Manufacturing, Inc. | 2007-10-23 |
| A-BSM BONE SUBSTITUTE MATERIAL (K072636) | Etex Corp. | 2007-10-23 |
| MOSAIC DEVICES (K071833) | Spinal Elements, Inc. | 2007-10-23 |
| SYNTHES CHRONOS COMPOSITE (K071046) | Synthes (Usa) | 2007-10-23 |
| FOX SV PTA CATHETER (K072824) | Abbott Laboratories | 2007-10-23 |
| RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS (K072768) | Lifecore Biomedical, Inc. | 2007-10-23 |
| ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J (K072705) | Asahi Intecc Co., Ltd. | 2007-10-23 |
| ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (K072519) | Activator Methods International, Ltd. | 2007-10-23 |
| ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR (K072655) | Genesee Biomedical, Inc. | 2007-10-23 |
| OLYMPUS DENTAL IMPLANT SYSTEM (K071070) | Keystone Dental, Inc. | 2007-10-23 |
| EXPANDING VASCULAR SHEATH (K070865) | Applied Medical | 2007-10-23 |
| NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG (K072362) | Novalung GmbH | 2007-10-23 |
| ONCONTROL BONE MARROW BIOPSY SYSTEM (K072045) | Vidacare Corporation | 2007-10-22 |
| BIS MODULE FOR ENVOY PATIENT MONITOR (K071899) | Mennen Medical , Ltd. | 2007-10-22 |
| QUANTRX FEMALE FERTILITY TEST (K070484) | Quantrx Biomedical Corporation | 2007-10-22 |
| CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (K071931) | Codman & Shurtleff, Inc. | 2007-10-22 |
| ORAL NEUTRALIZER (K071617) | Oral Biotech | 2007-10-19 |
| LANFAN POWDER-FREE VINYL EXAM GLOVES (K072488) | Shanghai Lanfan Co., Ltd. | 2007-10-19 |
| AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER (K062932) | Ahlstrom Mount Holly Springs, LLC | 2007-10-19 |
| BONALIVE GRANULES AND BONALIVE PLATES (K071937) | Vivoxid , Ltd. | 2007-10-19 |
| FLEX-STAR V (K072402) | Cmp Industries, LLC | 2007-10-19 |
| NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM (K072339) | Nuvasive, Inc. | 2007-10-19 |
| DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES (K072789) | Encision, Inc. | 2007-10-19 |
| ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638) | Roche Diagnostics Corp. | 2007-10-19 |
| NGARDE SYSTEM (K072685) | N Spine, Inc. | 2007-10-19 |
| CAPSEW PLICATION SYSTEM (K071796) | Cayenne Medical, Inc. | 2007-10-19 |
| PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR (K072235) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-10-19 |
| ATLAS SPINE PEDICLE SCREW SYSTEM (K072426) | Atlas Spine, LLC | 2007-10-19 |