| HYPERQ SYSTEM (K082564) | Biological Signal Processing, Ltd. | 2008-10-20 |
| DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 (K080854) | Suntech Medical, Inc. | 2008-10-20 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K082006) | American Medical Systems, Inc. | 2008-10-20 |
| PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS (K080629) | Promedical Products Co., Ltd. | 2008-10-20 |
| ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT (K073309) | Horiba Abx | 2008-10-17 |
| ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A (K083014) | Toshiba America Medical Systems, In.C | 2008-10-17 |
| GE XTREME INJECTOR OPTION (K082960) | Ge Medical Systems, LLC | 2008-10-17 |
| ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] (K081475) | Medtronic Xomed, Inc. | 2008-10-17 |
| ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM (K082375) | OrthoPediatrics Corp. | 2008-10-17 |
| MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE (K081594) | Medline Industries, Inc. | 2008-10-17 |
| BLACKSTONE PEDICLE SCREW SYSTEM (K082797) | Blackstone Medical, Inc. | 2008-10-17 |
| NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT (K082599) | Cnsystem Medizintechnik AG | 2008-10-17 |
| COLLAMEND FM IMPLANT (K082687) | C.R. Bard, Inc. | 2008-10-17 |
| ELLIPSE MULTIFLEX (K081408) | Ellipse A/S | 2008-10-17 |
| ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (K080909) | Ikonisys, Inc. | 2008-10-17 |
| STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS (K082545) | Institut Straumann AG | 2008-10-17 |
| POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K082370) | Smart Glove Corp. Sdn Bhd | 2008-10-17 |
| P3T ABDOMEN (K082458) | Medrad, Inc. | 2008-10-17 |
| SPIRALFUSE PERIPHERAL INFUSION SYSTEM (K082199) | Bacchus Vascular, Inc. | 2008-10-17 |
| INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (K080908) | Innercool Therapies, Inc.- A Delaware Corporation | 2008-10-17 |
| MICRUS MICROCOIL DELIVERY SYSTEM (K082739) | Micrus Endovascular Corporation | 2008-10-17 |
| ENCAGE BIPOLAR RF PROBE (K082954) | Trod Medical SA | 2008-10-17 |
| MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT (K081438) | Lifenet Health | 2008-10-17 |
| CDB CLIP (K080906) | Cdb Corporation | 2008-10-17 |
| TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD (K081348) | TriMed, Inc. | 2008-10-17 |
| CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB (K080923) | I-Sens, Inc. | 2008-10-17 |
| INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES (K082260) | Calvary Spine, LLC | 2008-10-17 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (K082640) | Coloplast Manufacturing Us, LLC | 2008-10-17 |
| ACCIN TOTAL KNEE SYSTEM (K081127) | Accelerated Innovation, LLC | 2008-10-17 |
| SPINAL USA VBR SYSTEM (K081196) | Spinal USA | 2008-10-16 |
| FIRMGRIP (K080793) | Flexicath , Ltd. | 2008-10-16 |
| MODIFICATION TO: CAPSTONE SPINAL SYSTEM (K082732) | Medtronic Sofamor Danek USA, Inc. | 2008-10-16 |
| NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V (K081759) | Zimmer GmbH | 2008-10-16 |
| VB IMAGE VIEWER (K080581) | Olympus Medical Systems Corporation | 2008-10-16 |
| STRAIGHT FIRE HOLMIUM LASER FIBER (K082928) | Boston Scientific Corp | 2008-10-16 |
| CRYSTALSERT CRYSTALENS DELIVERY SYSTEM (K082944) | Bausch & Lomb, Inc. | 2008-10-16 |
| COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 (K082051) | Cosman Medical, Inc. | 2008-10-16 |
| GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES (K082615) | Osteotech, Inc. | 2008-10-16 |
| OSDX HIP BMD SYSTEM (K082402) | Imaging Therapeutics, Inc. | 2008-10-16 |
| POLYBONE GRANULE & BLOCK (K082338) | Kyung Won Medical Co., Ltd. | 2008-10-16 |
| CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR (K082258) | Crosstex International | 2008-10-16 |
| CARAPASTE ORAL WOUND DRESSING (K082856) | Mcgrath Pharmaceuticals, Inc. | 2008-10-15 |
| VRIICU SYSTEM (K073582) | Deep Breeze , Ltd. | 2008-10-15 |
| NXSTAGE PUREFLOW SL (K080919) | Nxstage Medical, Inc. | 2008-10-15 |
| EVIS MD PLANTIUM BLUE (K082232) | Ageless Beauty Corporation | 2008-10-15 |
| VACORA VACUUM ASSISTED BIOPSY SYSTEM (K082681) | C.R. Bard, Inc. | 2008-10-15 |
| ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS (K082398) | Encore Medical L.P. | 2008-10-15 |
| HRB-127-32 HIGH RESOLUTION BRAIN COIL (K082916) | Invivo | 2008-10-15 |
| CURATIVE980 DIODE LASER (K082445) | Oroscience, Inc. | 2008-10-15 |
| DENSEO FAIRY (K082158) | Xpdent Corp | 2008-10-15 |
| VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 (K082890) | Vnus Medical Technologies, Inc. | 2008-10-15 |
| BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS (K082446) | Biomet, Inc. | 2008-10-15 |
| ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS (K082666) | Arthrocare Corp. | 2008-10-15 |
| FLOWPICC CONSOLE (K081626) | Vasonova, Inc. | 2008-10-15 |
| DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE (K082092) | Galemed Corp. | 2008-10-15 |
| PRELUDE SHORT SHEATH INTRODUCER (K082063) | Merit Medical Systems, Inc. | 2008-10-15 |
| HELONTIX VENT (K072926) | Linde Gas Therapeutics | 2008-10-15 |
| BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) (K081674) | The Binding Site, Ltd. | 2008-10-15 |
| XR-EXPRESS (K082336) | New Mexico Software, Inc. | 2008-10-15 |
| APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE (K081710) | American Medical Systems | 2008-10-15 |
| MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III (K082081) | Mako Surgical Corp. | 2008-10-15 |
| CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (K080632) | Clearlab SG Pte, Ltd. | 2008-10-15 |
| MRDH BANDAGE (K082703) | Marine Polymer Technologies, Inc. | 2008-10-14 |
| 4D VIEWER RADIOLOGY, MODEL USWP-100A (K082684) | Toshiba America Medical Systems, In.C | 2008-10-14 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE (K082447) | Rich Mountain Medical Products, Inc. | 2008-10-14 |
| GS III FIXTURE SYSTEM (K082213) | Osstem Implant Co., Ltd. | 2008-10-14 |
| SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (K082828) | Suturtek Incorporated | 2008-10-14 |
| SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 (K082543) | Sonocine, Inc. | 2008-10-14 |
| PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER (K081793) | Philips Medizin Systeme Boeblingen GmbH | 2008-10-14 |
| COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN (K082012) | Cosman Medical, Inc. | 2008-10-14 |
| DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (K080399) | Musculoskeletal Transplant Foundation | 2008-10-10 |
| ENSPLINTCMX CLAVICLE PIN (K081832) | Sonoma Orthopedic Products, Inc. | 2008-10-10 |
| CD HORIZON SPINAL SYSTEM (K082236) | Medtronic Sofamor Danek | 2008-10-10 |
| VITRIFICATION KIT & VITRIFICATION WARMING KIT (K073522) | Sage In-Vitro Fertilization, Inc. | 2008-10-10 |
| HEM-9000AI (K081654) | Omron Healthcare, Inc. | 2008-10-10 |
| 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT (K073368) | Bicon, LLC | 2008-10-10 |
| INFX-8000H, INFINIX-I (K082830) | Toshiba America Medical Systems, In.C | 2008-10-10 |
| STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER (K082675) | Diagnostica Stago, Inc. | 2008-10-10 |
| SOMATOM FLASH DS (K082220) | Siemens Medical Solutions USA, Inc. | 2008-10-10 |
| AURAGEN CORTICAL SURFACE ELECTRODES (K082250) | Integra Neurosciences | 2008-10-10 |
| KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO (K082046) | KARL STORZ Endoscopy-America, Inc. | 2008-10-10 |
| SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER (K081890) | Sysmex America, Inc. | 2008-10-10 |
| MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK (K082052) | Masimo Corporation | 2008-10-10 |
| NUVASIVE SPHERX SYSTEM (K082332) | Nuvasive, Inc. | 2008-10-10 |
| T2 FLEXIBLE NAIL (K082018) | Howmedica Osteonics Corp. | 2008-10-10 |
| CENTERING INTRALUMINAL APPLICATOR (K082653) | Varian Medical Systems, Inc. | 2008-10-10 |
| A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (K080851) | Anticancer, Inc. | 2008-10-10 |
| PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS (K082959) | Unimed Medical Supplies, Inc. | 2008-10-10 |
| TEMPUSIC PATIENT MONITOR (K082718) | Remote Diagnostic Technologies , Ltd. | 2008-10-10 |
| LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 (K082680) | Siemens Healthcare Diagnostics | 2008-10-10 |
| EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY (K082702) | Exactech, Inc. | 2008-10-10 |
| PAX-500 (K082350) | VATECH Co., Ltd. | 2008-10-10 |
| CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS (K081107) | K2m, Inc. | 2008-10-10 |
| STARR FRAME STEINMANN PIN (K082017) | Starr Frame, LLC | 2008-10-10 |
| TRICOS A RESORBABLE BONE SUBSTITUTE (K081717) | Baxter Healthcare Corp | 2008-10-10 |
| NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K080275) | Iasis Medical, Inc. | 2008-10-09 |
| THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK (K081670) | Cardinal Health 207, Inc. | 2008-10-09 |
| PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION (K082330) | Primary Care Solutions, Inc. | 2008-10-09 |
| UltraClot, UltraClot OTC (K082601) | Emergency Medical Devices, LLC | 2008-10-09 |
| PIVOT ASSIST (K081053) | Pivot Assist, LLC | 2008-10-09 |