| XPERT MRSA/SA BLOOD CULTURE ASSAY (K082140) | Cepheid | 2008-09-29 |
| QUICKPIN (K082752) | Laboratorios Grifols, S.A. | 2008-09-29 |
| VENTRIO HERNIA PATCH (K081777) | C.R. Bard, Inc. | 2008-09-29 |
| PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR (K081865) | CooperVision, Inc. | 2008-09-29 |
| UNIVERSAL ELECTRODES (K081871) | Neurometrix, Inc. | 2008-09-29 |
| AED BIPOLAR FORCEPS, MODEL 13-1646 (K081553) | National Advanced Endoscopy Devices, Inc. | 2008-09-29 |
| HASELMEIER PEN 8 (K082616) | Haselmeier GmbH | 2008-09-26 |
| UNISYN IMAGE FUSION, VERSION 1.0 (K081987) | Convergent Imaging Solutions | 2008-09-26 |
| VIDAS AFP ASSAY (K080017) | bioMerieux, Inc. | 2008-09-26 |
| SEEPLATE CERVICAL PLATE SYSTEM (K082037) | Amedica Corp. | 2008-09-26 |
| ACUNAV V ULTRASOUND CATHETER (K081808) | Siemens Medical Solutions USA, Inc. | 2008-09-26 |
| LIFEBED PATIENT VIGILANCE SYSTEM (K082366) | Hoana Medical, Inc. | 2008-09-26 |
| GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION (K082317) | General Electric Co. | 2008-09-26 |
| UNITED U2 PATELLA (K082469) | United Orthopedic Corp. | 2008-09-26 |
| MODIFICATION TO FETCH ASPIRATION CATHETER (K081989) | Possis Medical, Inc. | 2008-09-26 |
| OSSTELL ISQ IMPLANT STABILITY METER (K082523) | Osstell AB | 2008-09-26 |
| HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH (K080948) | Olympus Medical Systems Corporation | 2008-09-26 |
| SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE (K082029) | Ever Light Plastic Products Co., Ltd. | 2008-09-26 |
| ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 (K081231) | Abbott Laboratories | 2008-09-26 |
| DUOFLO CATHETER (K080700) | Thermopeutix, Inc. | 2008-09-26 |
| ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS (K081860) | Zimmer, Inc. | 2008-09-26 |
| GALAXY 55 (K082685) | Larsen & Toubro Limited | 2008-09-26 |
| LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE (K082256) | Integrated Medical Systems, Inc. | 2008-09-26 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K081539) | Rich Mountain Medical Products, Inc. | 2008-09-26 |
| SMOOTHKIT+ (K082004) | Osyris | 2008-09-26 |
| DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K082443) | Rich Mountain Medical Products, Inc. | 2008-09-26 |
| FLOWPICC STYLET (K081625) | Vasonova, Inc. | 2008-09-26 |
| MINI GHOST, MODEL: 507 (K082524) | NuMED, Inc. | 2008-09-26 |
| PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX (K082167) | Digimed Corporation | 2008-09-26 |
| FINECROSS MG CORONARY MICRO-GUIDE CATHETER (K082519) | Terumo Medical Corp. | 2008-09-26 |
| HANDHELD ECG MONITOR, MODEL MD100 (K080933) | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-09-26 |
| BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 (K082449) | Bisco, Inc. | 2008-09-25 |
| INJEKT FILIFORM INJECTION NEEDLE (K082319) | Cook Urological, Inc. | 2008-09-25 |
| AED MONOPOLAR LAP ACCESSORIES (K081503) | National Advanced Endoscopy Devices, Inc. | 2008-09-25 |
| K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME (K081236) | Mcneil-Ppc, Inc. | 2008-09-25 |
| L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS (K081489) | Peter Lazic GmbH | 2008-09-25 |
| BISQUE ZIRCONIA BLANKS, TYPE BYZ (K081850) | Zircar Zirconia, Inc. | 2008-09-25 |
| PROLONG (K081864) | Life-Tech, Inc. | 2008-09-25 |
| SERIM DISINTEK OPA TEST STRIP (K082352) | Serim Research Corp. | 2008-09-25 |
| MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) (K081386) | Esaote, S.p.A. | 2008-09-25 |
| MODIFICATION TO HAMILTON-G5 (K081521) | Hamilton Medical AG | 2008-09-25 |
| AUDICOR SENSOR, MODELS: 2.0, 3.0 (K080602) | Inovise Medical, Inc. | 2008-09-25 |
| TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T (K082636) | Quality Electrodynamics | 2008-09-25 |
| AW SERVER (K081985) | Ge Medical Systems, LLC | 2008-09-25 |
| ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT (K080164) | Zimmer Dental, Inc. | 2008-09-25 |
| CHOOSTENT (K072094) | M.I.Tech Co., Ltd. | 2008-09-25 |
| T12S TELEMETRY TRANSMITTER (K081800) | Mortara Instrument, Inc. | 2008-09-24 |
| RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (K082736) | Terumo Medical Corp. | 2008-09-24 |
| OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE (K082491) | Ceremed , Inc. | 2008-09-24 |
| NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363) | Advanced Medical Solutions Limited | 2008-09-24 |
| DAMON 4CLEAR (K081415) | Ormco Corp. | 2008-09-24 |
| XPERT MRSA/SA SSTI ASSAY (K080837) | Cepheid | 2008-09-24 |
| HEART SYNC PEDIATRIC, MODEL PED-100 (K081442) | Heart Sync, LLC | 2008-09-24 |
| ACCELL TBM-R (K081817) | Isotis Orthobiologics, Inc. | 2008-09-24 |
| MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM (K081883) | Us Spine | 2008-09-24 |
| NUVASIVE LATERAL PLATE SYSTEM (K082070) | Nuvasive, Inc. | 2008-09-24 |
| SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (K081371) | Leonhard Lang GmbH | 2008-09-24 |
| SELLAS (K080382) | Dinona Co., Ltd. | 2008-09-24 |
| ULTRAEXTEND USWS-900A (K082596) | Toshiba America Medical Systems, In.C | 2008-09-23 |
| 4CIS SOLAR AND APOLLON SPINE SYSTEMS (K082453) | Solco Biomedical Co., Ltd. | 2008-09-23 |
| HYGEIA-5 OXYGEN CONCENTRATOR (K081267) | Kedl Internation Limited | 2008-09-23 |
| PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) (K081904) | Medcomp | 2008-09-23 |
| MENICON Z RIGID GAS PERMEABLE CONTACT LENS (K081443) | Menicon Co, Ltd. | 2008-09-23 |
| SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS (K081472) | AngioDynamics, Inc. | 2008-09-23 |
| DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 (K082645) | Siemens Healthcare Diagnostics | 2008-09-22 |
| TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER (K081514) | Lang Dental Mfg. Co., Inc. | 2008-09-22 |
| PLANISIGHT LINASYS (K082228) | Pathfinder Therapeutics, Inc. | 2008-09-22 |
| UNIVATION UNICONDYLAR KNEE SYSTEM (K081293) | Aesculap Implant Systems, Inc. | 2008-09-22 |
| VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 (K080803) | American Optisurgical, Inc. | 2008-09-22 |
| CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS (K081743) | Draeger Medical AG & Co. KG | 2008-09-22 |
| NOVEL CERVICAL SPINAL SPACER SYSTEM (K081730) | Alphatec Spine, Inc. | 2008-09-19 |
| RAYPAX SYSTEM (K081948) | Raypax, Inc. | 2008-09-19 |
| LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM (K073498) | Rudolf Medical GmbH + Co. KG | 2008-09-19 |
| MODIFIED ENDO STICH (K082659) | Covidien Lp, Formerly Registered AS United States | 2008-09-19 |
| ACRYDERM ABSORBENT OXYGEN DRESSING (K082459) | Acrymed, Inc. | 2008-09-19 |
| GOLOX-93 (K081779) | Respironics, Inc. | 2008-09-19 |
| ICSI CUMULASE (K081639) | Medicult A/S | 2008-09-19 |
| DIZZYFIX (K081602) | Clearwater Clinical Limited | 2008-09-19 |
| TYMPANOSTOMY TUBE (K082188) | Acclarent, Inc. | 2008-09-19 |
| MDI MII ONE-PIECE IMPLANT, 2.9MM (K081653) | Imtec Corp. | 2008-09-19 |
| TANDEMHEART TRANSSEPTAL CANNULA- EF 72 (K082425) | Cardiacassist, Inc. | 2008-09-18 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 (K082395) | Bionostics, Inc. | 2008-09-18 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 (K081451) | Bionime Corporation | 2008-09-18 |
| INFILTRATION KIT (K081493) | Dmg USA, Inc. | 2008-09-18 |
| GLIDESHEATH (K082644) | Terumo Medical Corp. | 2008-09-18 |
| ZOLL R SERIES (K081574) | ZOLL Medical Corporation | 2008-09-18 |
| ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE (K082569) | Entellus Medical, Inc. | 2008-09-18 |
| AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (K082245) | Ceremed , Inc. | 2008-09-18 |
| ZENO AI ECO DISC (K082257) | Wieland Dental + Technik GmbH & Co. KG | 2008-09-18 |
| SOMNOWATCH (K081485) | Somnomedics GmbH | 2008-09-18 |
| S40 CREATINE KINASE (CK) (K082226) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 |
| VIVASCOPE SYSTEM, MODEL 1500, 3000 (K080788) | Lucid, Inc. | 2008-09-17 |
| OSSEOSPEED TM PROFILE SYSTEM (K080156) | Astra Tech AB | 2008-09-17 |
| SURSHIELD SAFETY I.V. CATHETER (K082362) | Terumo Medical Corp. | 2008-09-17 |
| PRIMADO SURGICAL DRILL (K080722) | Nakanishi, Inc. | 2008-09-17 |
| G-MOPS G5 SERIES (K081115) | Vitrolife Sweden AB | 2008-09-17 |
| SPY ANALYSIS TOOLKIT, MODEL SA9000 (K081792) | Novadaq Technologies, Inc. | 2008-09-17 |
| BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 (K081742) | Baxano, Inc. | 2008-09-17 |
| PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL (K081810) | Pulpdent Corporation | 2008-09-17 |
| LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN (K081705) | Lang Dental Mfg. Co., Inc. | 2008-09-17 |