| MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS (K063223) | CooperSurgical, Inc. | 2008-01-23 |
| STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT (K073018) | Brainlab AG | 2008-01-23 |
| FLAATZ 750 (K080064) | Drtech Corp. | 2008-01-23 |
| SILK'N (K072906) | Home Skinovations , Ltd. | 2008-01-23 |
| OPTILITE HOLMIUM LASER FIBERS (K073496) | Cook Urological, Inc. | 2008-01-23 |
| VASCUVIEW ULTRASOUND SYSTEM (K080049) | Escalon Medical Corp. | 2008-01-23 |
| INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN (K073014) | Autogenomics, Incorporated | 2008-01-23 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K080004) | Sicel Technologies, Inc. | 2008-01-23 |
| SELF-ADHESIVE RESIN CEMENT (K073173) | Dentsply Interntional | 2008-01-23 |
| VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K073406) | bioMerieux, Inc. | 2008-01-23 |
| VERSA LITE (K073503) | Diomedics, Inc. | 2008-01-23 |
| IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 (K071883) | Cyden Limited | 2008-01-23 |
| JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 (K071774) | Maquet Cardiopulmonary, AG | 2008-01-23 |
| ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT (K073464) | AngioDynamics, Inc. | 2008-01-23 |
| DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (K072762) | Depalt, Inc. | 2008-01-22 |
| BOSTON-BAND CRANIAL REMODLING ORTHOSIS (K072862) | Boston Brace Intl., Inc. | 2008-01-22 |
| DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, (K073093) | Spire Biomedical, Inc. | 2008-01-22 |
| I-PAD (K062970) | Cu Medical Systems, Inc. | 2008-01-22 |
| VANTAGE TITAN, MODEL MRT-1504/S3 (K080038) | Toshiba America Medical Systems, In.C | 2008-01-22 |
| SYNOCTA ABUTMENTS (K073628) | Straumann USA | 2008-01-22 |
| TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) (K072770) | Oscor, Inc. | 2008-01-22 |
| MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE (K072420) | Oceanic Medical Products, Inc. | 2008-01-22 |
| RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT (K072736) | Rhythmlink International, LLC | 2008-01-22 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K073424) | Trek Diagnostic Systems, Inc. | 2008-01-22 |
| DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523) | General Atomics | 2008-01-22 |
| NIO 5MP DISPLAY, MODEL E5620 (K072875) | Barcoview, Medical Imaging Systems | 2008-01-22 |
| CYTOPHIL TISSUE MARKER (K072219) | Cytophil, Inc. | 2008-01-18 |
| NICOM ELECTRODES (K071631) | Cheetah Medical, Inc. | 2008-01-18 |
| PATRIOT SPACERS (K072970) | Globus Medical, Inc. | 2008-01-18 |
| MICROMRI WRIST COIL (K073131) | Micromri, Inc. | 2008-01-18 |
| PATRIOT SPACERS: COLONIAL ACDF (K072991) | Globus Medical, Inc. | 2008-01-18 |
| BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES (K072124) | Black & Black Surgical, Inc. | 2008-01-18 |
| OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL (K073310) | Hitachi Medical Corp. | 2008-01-18 |
| MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM (K073292) | Heeyoung Co., Ltd. | 2008-01-18 |
| ENTERAL FEEDING SPIKE ADAPTER (K072652) | Cedic S.R.L. | 2008-01-18 |
| MODIFICATION TO THERMAGE THERMACOOL SYSTEM (K072849) | Thermage, Inc. | 2008-01-18 |
| DERMAPAL WITH DIGITAL TIMER (K073587) | Daavlin Distributing Co. | 2008-01-18 |
| CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 (K072635) | Ningbo Huahui Medical Instruments Co., Ltd. | 2008-01-17 |
| AURAVENEER CEMENT (K073101) | Denali Corporation | 2008-01-17 |
| IMIX INSIGHT X-RAY SYSTEMS (K073114) | Imix Adr Finland OY | 2008-01-17 |
| TENDER ORTHO BOND-ENA BOND-ENA ETCH (K072978) | Micerium S.P.A. | 2008-01-17 |
| REGISTRATION AND FUSION (K080013) | Agfa Healthcare Corporation | 2008-01-17 |
| ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT (K071456) | Arthrex, Inc. | 2008-01-17 |
| PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (K073662) | Playtex Products, Inc. | 2008-01-17 |
| GILB-2, GLASS IONOMER PROTECTIVE COATING (K073395) | 3M Espe Dental Products | 2008-01-17 |
| GRYPHON BR AND HEALIX BR ANCHORS (K073412) | Depuy Mitek, A Johnson & Johnson Company | 2008-01-17 |
| CHEETAH RELIANT, CHEETAH ACTIVE (K072662) | Cheetah Medical, Inc. | 2008-01-16 |
| ORTHO-WRAP BIORESORBABLE SHEET (K072190) | Mast Biosurgery | 2008-01-16 |
| CHAMELEON FIXATION SYSTEM (K071420) | Spinefrontier, Inc. | 2008-01-16 |
| PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 (K063091) | Tyrx Pharma, Inc. | 2008-01-16 |
| NEEDLE-TRAP/NEEDLE SAFETY LABEL (K073206) | Schreiner Medipharm | 2008-01-16 |
| PORTABLE ECSCOPE 12I (K080036) | Dyansys, Inc. | 2008-01-16 |
| BIPORE BALLOON DILATION CATHETER (K073318) | Bipore, Inc. | 2008-01-16 |
| RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J (K073090) | C.R. Bard, Inc. | 2008-01-15 |
| PRESSURE INJECTABLE PICC (K073451) | Arrow International, Inc. | 2008-01-15 |
| ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 (K072149) | Phadia US, Inc. | 2008-01-15 |
| START JUNIOR (K073512) | Otto Bock Healthcare LP | 2008-01-14 |
| RICHTER MALE LATEX CONDOM (K070511) | Richter Rubber Technology Sbn Bhd | 2008-01-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML (K073433) | Becton, Dickinson & CO | 2008-01-14 |
| JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM (K072917) | Odontit S.A. | 2008-01-14 |
| MERITS E700 PORCE LIFT (K073513) | Merits Health Products Co., Ltd. | 2008-01-14 |
| POINTCARE NOW SYSTEM (K072869) | Pointcare Technologies, Inc. | 2008-01-14 |
| FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T (K073431) | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 |
| MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) (K072870) | Foundry Newco X, Inc. | 2008-01-14 |
| FINGERTIP PULSE OXIMETER, MODEL MD300I (K072825) | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-01-14 |
| EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 (K073473) | Volcano Corporation | 2008-01-14 |
| ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM (K071104) | Flier'S Quality Water Systems, Inc. | 2008-01-14 |
| INNERVUE DIAGNOSTIC SCOPE SYSTEM (K072879) | Biomet Orthopedics, Inc. | 2008-01-14 |
| LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 (K072688) | International Biophysics Corp. | 2008-01-11 |
| HYDROCOIL EMBOLIC SYSTEMS (HES) (K071939) | MicroVention, Inc. | 2008-01-11 |
| SLIT LAMP (K073190) | Huvitz Co., Ltd. | 2008-01-11 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) (K073198) | Microlife Intellectual Property GmbH | 2008-01-11 |
| MICROSHEATH XL CATHETERS (K073289) | Flowcardia, Inc. | 2008-01-11 |
| CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 (K072790) | Confluent Surgical,Inc | 2008-01-11 |
| EEG-1100A SWITCH BOX (K073491) | Nihon Kohden America, Inc. | 2008-01-11 |
| MODIFICATION TO: BPCARD, MODEL Z-7000-0700 (K073630) | Qrs Diagnostic, LLC | 2008-01-11 |
| MODIFICATION TO: ARAGON SURGICAL LAPCAP (K073452) | Aragon Surgical, Inc. | 2008-01-11 |
| MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES (K073462) | Ge Medical Systems Information Technologies | 2008-01-11 |
| A&J POCA01 OXYGEN CONCENTRATOR (K071608) | Zhongshan A&J Medical Equipment Co., Ltd. | 2008-01-11 |
| CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B (K073038) | Carematix, Inc. | 2008-01-11 |
| TRANS1 AXIAL FIXATON SYSTEM (K073514) | Trans1 Incorporated | 2008-01-11 |
| HEARTEVENT, MODEL AT (K072385) | Diagnostic Devices Pty, Ltd. | 2008-01-11 |
| NOBELREPLACE HEXAGONAL IMPLANT (K073142) | Nobel Biocare USA, LLC | 2008-01-11 |
| AVIATOR INSULIN PUMP (K071788) | Abbott Diabetes Care, Inc. | 2008-01-11 |
| PC-180 / PRINCE 180 EASY ECG MONITOR (K073152) | Shenzhen Creative Industry Co., Ltd. | 2008-01-10 |
| INTUITION, MODEL 0170 (K073632) | Arcoma AB | 2008-01-10 |
| SYNTHES OC FUSION AND SYNAPSE SYSTEMS (K072434) | Synthes Spine Co.Lp | 2008-01-10 |
| REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) (K072888) | Encore Medical L.P. | 2008-01-10 |
| SPY FLUORESCENT IMAGING SYSTEM (K073130) | Novadaq Technologies, Inc. | 2008-01-10 |
| MS SYSTEM (PROVISIONAL) (K072871) | Osstem Implant Co., Ltd. | 2008-01-10 |
| SPY FLUORESCENT IMAGING SYSTEM (K073088) | Novadaq Technologies, Inc. | 2008-01-10 |
| MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES (K071782) | Micromed S.P.A. | 2008-01-10 |
| CANDELA-INOLASE SERENITY PRO PSF SYSTEM (K072925) | Inolase, Ltd. | 2008-01-10 |
| SMITH & NEPHEW MIS HIP STEM (K072417) | Smith & Nephew, Inc. | 2008-01-10 |
| VARI-LASE WIRE FIBER (K072332) | Vascular Solutions, Inc. | 2008-01-10 |
| PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM (K072703) | Pioneer Surgical Technology | 2008-01-10 |
| ACCIN HIP SYSTEM (K073068) | Accelerated Innovation, LLC | 2008-01-10 |
| CPS COURIER GUIDEWIRE (K073082) | Brivant, Ltd. | 2008-01-09 |
| SCIMAGE PICOMENTERPRISE (K073169) | Scimage, Inc. | 2008-01-09 |
| F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (K072432) | Hand Biomechanics Lab, Inc. | 2008-01-09 |