| PERFADEX WITH THAM (K081997) | Vitrolife Sweden AB | 2008-10-09 |
| MODIFICATION TO MIRAGE MICRO (K081321) | Resmed, Ltd. | 2008-10-09 |
| PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST (K082237) | Mallinckrodt Developpement France | 2008-10-09 |
| OXISCAN II DATA MANAGEMENT SYSTEM (K080348) | Airsep Corp. | 2008-10-09 |
| UNISCAN -DOA SYSTEM (K080347) | Taiwan Unison Biotech, Inc. | 2008-10-09 |
| URESTA PESSARY (K081385) | Eastmed, Inc. | 2008-10-09 |
| MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B (K082802) | Learning Curve Brands Inc. the First Years | 2008-10-09 |
| DIO SM IMPLANT SYSTEM (K080559) | Dsi, Inc. | 2008-10-09 |
| VIDAS CEA (S) ASSAY (K080194) | bioMerieux, Inc. | 2008-10-09 |
| OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES (K081178) | Contamac, Ltd. | 2008-10-09 |
| LDR SPINE EASYSPINE SYSTEM (K082592) | Ldr Spine USA | 2008-10-08 |
| BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 (K081187) | Bridgepoint Medical | 2008-10-08 |
| GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE (K082486) | Bayer Healthcare, LLC | 2008-10-08 |
| ZONARE ULTRA ULTRASOUND SYSTEM (K082326) | Zonare Medical Systems, Inc. | 2008-10-08 |
| RTX RESPIRATOR (K082657) | Medivent Limited | 2008-10-08 |
| FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO (K081447) | Draeger Medical AG & Co. KG | 2008-10-08 |
| SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR (K082280) | Philips Medical Systems North America Co. | 2008-10-08 |
| WELL LEAD SILICONE AND LATEX FOLEY CATHETERS (K082815) | Well Lead Medical Instruments | 2008-10-08 |
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
| EXSUDEX WOUND DRAINAGE PUMP (K082311) | The Medical Company | 2008-10-08 |
| S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229) | Volcano Corporation | 2008-10-08 |
| LTM WOUND DRESSING (K082103) | Lifecell Corp. | 2008-10-08 |
| MAYFIELD MR/X-RAY SKULL CLAMP (K081401) | Integra Lifesciences Corp. | 2008-10-08 |
| TRACHEOSCOPIC VENTILATION TUBE (TVT) (K082420) | Etview | 2008-10-08 |
| ICON, MODEL C3 (K082242) | Osypka Medical, Inc. | 2008-10-08 |
| EVIS MD PLATINUM RED LIGHT THERAPY (K082247) | Ageless Beauty Corporation | 2008-10-08 |
| POWERLIPO LASER SYSTEM (K082096) | Lutronic Corporation | 2008-10-08 |
| GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM (K082816) | Ge Medical Systems, LLC | 2008-10-08 |
| MAJOR.BASE 20 (K081884) | Major Prodotti Dentari S.P.A. | 2008-10-08 |
| HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B (K082202) | Barrx Medical, Incorporated | 2008-10-08 |
| GE LIGHTSPEED 7.2 CT SCANNER SYSTEM (K082761) | Ge Medical Systems, LLC | 2008-10-08 |
| NEUROSTAR TMS SYSTEM (DEN070003) | Neuronetics | 2008-10-07 |
| RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 (K082608) | Stryker Spine | 2008-10-07 |
| ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 (K082618) | Taidoc Technology Corporation | 2008-10-07 |
| JUMAO MANUAL WHEELCHAIR (K082784) | Danyang Jumao Healthcare Equipment Co., Ltd. | 2008-10-07 |
| SYNERGY SPINAL SYSTEM (6.35 POLARIS) (K081952) | Biomet Spine | 2008-10-07 |
| ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS (K081666) | Astra Tech, Inc. | 2008-10-07 |
| BARD 3DMAX MESH (K081010) | Davol Inc., Sub. C. R. Bard, Inc. | 2008-10-07 |
| MODIFICATION TO MICROFUSE BONE VOID FILLER (K082442) | Globus Medical, Inc. | 2008-10-07 |
| STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 (K081935) | Aktina Medical Physics Corp. | 2008-10-07 |
| SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) (K082032) | Abbott Spine, Inc. | 2008-10-06 |
| GRIND NO MORE (K082301) | Placontrol, Inc. | 2008-10-06 |
| RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM (K082217) | Arizant Healthcare, Inc. | 2008-10-06 |
| SEN-4100 ELECTRIC STIMULATOR (K071969) | Nihon Kohden America, Inc. | 2008-10-06 |
| FLUCONAZOLE 25UG BBL SENSI-DISC (K082271) | Becton, Dickinson & CO | 2008-10-06 |
| RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (K081478) | Bionostics, Inc. | 2008-10-06 |
| JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 (K082664) | Pathway Medical Technologies, Inc. | 2008-10-06 |
| COLOR LCD MONITOR (K082663) | Eizo Nanao Corporation | 2008-10-06 |
| LYMPHA PRESS OPTIMAL, MODEL# 1201AP (K082149) | Mego Afek AC , Ltd. | 2008-10-06 |
| BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (K082661) | Princeton BioMeditech Corp. | 2008-10-06 |
| AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR (K081820) | Avalon Laboratories, LLC | 2008-10-06 |
| PASS LP SPINAL SYSTEM (K082577) | Medicrea Technologies | 2008-10-03 |
| QUART ARTERIAL FILTER WITH BIOLINE COATING (K082544) | Maquet Cardiopulmonary, AG | 2008-10-03 |
| ML830TP (K080786) | Microlight Corporation of America | 2008-10-03 |
| STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (K082567) | Howmedica Osteonics Corp. | 2008-10-03 |
| AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR (K081933) | Avalon Laboratories, LLC | 2008-10-03 |
| ENGSTROM CARESTATION, ENGSTROM PRO (K081842) | Datex-Ohmeda, Inc. | 2008-10-03 |
| ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX (K082515) | Asahi Kasei Medical Co., Ltd. | 2008-10-03 |
| IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (K080825) | Impedimed Pty , Ltd. | 2008-10-03 |
| INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 (K082633) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008-10-03 |
| GORE TRI-LOBE BALLOON CATHETER (K081799) | W. L. Gore & Associates, Inc. | 2008-10-03 |
| PASS 2 SPINAL SYSTEM (K082069) | Medicrea Technologies | 2008-10-03 |
| STRYKER ESSX WITH NAVIGATION MOUNT (K080052) | Stryker Corp. | 2008-10-02 |
| 6F PROXIS SYSTEM (K073700) | St. Jude Medical, Inc. | 2008-10-02 |
| LBI EMBOLECTOMY SYSTEM (K080901) | Lumen Biomedical, Inc. | 2008-10-02 |
| STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) (K081995) | Stryker Endoscopy | 2008-10-02 |
| ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (K082106) | Elcam Medical Acal | 2008-10-02 |
| ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT (K082071) | Adpharma, Inc. | 2008-10-02 |
| ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545) | Advanced Medical Optics, Inc. | 2008-10-02 |
| VORICONAZOLE 1UG BBL SENSI-DISC (K082272) | Becton, Dickinson & CO | 2008-10-02 |
| ATLAS SPINE SPACER (K081880) | Atlas Spine, Inc. | 2008-10-02 |
| SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (K082520) | Mallinckrodt Medical | 2008-10-02 |
| BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B (K082461) | MicroVention, Inc. | 2008-10-02 |
| BOVIE ICON GENERAL PURPOSE RF GENERATOR (K082109) | Bovie Medical | 2008-10-02 |
| DYNAMATRIX (K082058) | Cook Biotech, Inc. | 2008-10-02 |
| AUTO-SAFETY INJECTOR-2 (ASI-2) (K082587) | Medical House Products Limited | 2008-10-02 |
| NUVASIVE COROENT SYSTEM (K081611) | Nuvasive, Inc. | 2008-10-02 |
| LUMAPROBE (K073000) | Clareblend, Inc. | 2008-10-01 |
| OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 (K081893) | Arthrocare Corp. | 2008-10-01 |
| STRAUMANN WN CARES TITANIUM ABUTMENT (K082764) | Institut Straumann AG | 2008-10-01 |
| MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER (K082707) | Medx Electronics, Inc. | 2008-10-01 |
| NEOMED POLYURETHANE FEEDING TUBE (K082238) | Neomed, Inc. | 2008-10-01 |
| CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 (K073022) | Clareblend, Inc. | 2008-10-01 |
| MAGNETOM C! (K082331) | Siemens Medical Solutions USA, Inc. | 2008-10-01 |
| SMARTSIGNS MINPULSE (K081572) | Huntleigh Healthcare , Ltd. | 2008-10-01 |
| IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 (K082510) | Tomtec Imaging Systems GmbH | 2008-10-01 |
| MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM (K082757) | Bioplate, Inc. | 2008-10-01 |
| ENCORE SHOULDER REVISION GLENOID (K081448) | Encore Medical L.P. | 2008-09-30 |
| COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (K081425) | Cook Vascular, Inc. | 2008-09-30 |
| AVANTE Z ZIRCONIA (AS)3 BLOCKS (K081749) | Pentron Ceramics, Inc. | 2008-09-30 |
| IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR (K082364) | Topcon Corp. | 2008-09-30 |
| APPLIED BIOSYSTEMS 7500 FAST DX (K082562) | Applied Biosystems, Inc. | 2008-09-30 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED (K082444) | Rich Mountain Medical Products, Inc. | 2008-09-30 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL (K080570) | Centers for Disease Control and Prevention | 2008-09-30 |
| CIVASTRING PD-103 (K082159) | Civatech Oncology, Inc. | 2008-09-30 |
| COLLIEVA (K081782) | Innocoll Pharmaceuticals | 2008-09-30 |
| POWDER-FREE VINYL EXAMINATION GLOVES (K081658) | Jiangsu Alfa Glove Co., Ltd. | 2008-09-30 |
| MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT (K082656) | Fukuda Denshi USA, Inc. | 2008-09-30 |
| SECURACATH CATHETER, MODEL SPK01 (K082047) | Interrad Medical, Inc. | 2008-09-30 |
| AVAULTA SUPPORT SYSTEM (K082571) | C.R. Bard, Inc. | 2008-09-30 |