| TRU FLU (K071657) | Meridian Bioscience, Inc. | 2007-11-15 |
| A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE (K072593) | Healthstats International Pte. , Ltd. | 2007-11-15 |
| EARLYSENSE ES-16 SYSTEM (K070375) | Earlysense, Ltd. | 2007-11-15 |
| ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS (K072769) | Possis Medical, Inc. | 2007-11-14 |
| ODYSSEY WORKSTATION (K072371) | Stereotaxis, Inc. | 2007-11-14 |
| SATURN 9000-550 (K072984) | New Medical Co., Ltd. | 2007-11-14 |
| RESOLVE BILIARY DRAINAGE CATHETER (K063733) | Merit Medical Systems, Inc. | 2007-11-14 |
| VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR (K071895) | STERIS Corporation | 2007-11-14 |
| ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES (K072554) | Sable Industries, Inc. | 2007-11-14 |
| TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER (K072549) | C.R. Bard, Inc. | 2007-11-14 |
| DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 (K073056) | Vieworks Co., Ltd. | 2007-11-13 |
| DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR (K071224) | Dade Behring, Inc. | 2007-11-13 |
| OTODYNAMICS OTOPORT (K072033) | Otodynamics, Ltd. | 2007-11-13 |
| SATURN 9000-750 (K072983) | New Medical Co., Ltd. | 2007-11-13 |
| ACUSON S2000 ULTRASOUND SYSTEM (K072786) | Siemens Medical Solutions USA, Inc. | 2007-11-13 |
| ACCESSA CHOLESTEROL PANEL (K063852) | Home Access Health Corp. | 2007-11-09 |
| FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD (K072479) | Rapid Injection Systems Corp. | 2007-11-09 |
| THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 (K071826) | Fox Hollow Technologies | 2007-11-09 |
| VASCUTRAK II PTA DILATATION CATHETER (K073025) | Thermopeutix, Inc. Dba Ymed, Inc. | 2007-11-09 |
| CXI SUPPORT CATHETER (K072724) | Cook, Inc. | 2007-11-09 |
| ADVANTIV SAFETY I.V. CATHETER (K072419) | Smiths Medical Asd, Inc. | 2007-11-09 |
| HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM (K071413) | Arthrosurface, Inc. | 2007-11-09 |
| MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM (K071760) | Varian Medical Systems, Inc. | 2007-11-09 |
| MASTERGRAFT PUTTY (K071813) | Medtronic Sofamor Danek | 2007-11-09 |
| ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM (K071890) | Alphatec Spine, Inc. | 2007-11-09 |
| TRILOGY SYSTEM WITH RAPIDARC (K072916) | Varian Medical Systems, Inc. | 2007-11-09 |
| PRIMACONNEX CAD/CAM ABUTMENT SYSTEM (K072241) | Lifecore Biomedical, Inc. | 2007-11-09 |
| PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 (K072378) | Arthrex, Inc. | 2007-11-09 |
| MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM (K072748) | Cardiovascular Systems, Inc. | 2007-11-09 |
| SPEEDICATH COMPACT (K072808) | Coloplast Corp. | 2007-11-09 |
| DEPUY SPA POROUS COATED PROXIMAL SLEEVE (K071059) | DePuy Orthopaedics, Inc. | 2007-11-09 |
| OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER (K072156) | Usci Ireland | 2007-11-09 |
| KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (K072216) | Kapp Surgical Instrument, Inc. | 2007-11-09 |
| VIAPEEL PEELABLE INTRODUCER (K072248) | Enpath Medical, Inc. | 2007-11-09 |
| TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT (K073016) | Church & Dwight Co., Inc. | 2007-11-09 |
| TESLA GUARD, MODEL EFT G04 (K071802) | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007-11-09 |
| CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 (K071918) | Thermogear, Inc. | 2007-11-09 |
| T.B.R. ZIRCONNECT (K070935) | Sudimplant SA | 2007-11-09 |
| POLYGRAFT BGS (K062607) | Smith & Nephew, Inc. | 2007-11-09 |
| SUPERCABLE GRIP AND PLATE SYSTEM (K072250) | Kinamed, Inc. | 2007-11-09 |
| LUCENT (K071724) | Spinal Elements, Inc. | 2007-11-09 |
| SPY FLUORESCENT IMAGING SYSTEM (K071619) | Novadaq Technologies, Inc. | 2007-11-09 |
| EMULATE ADVANCED (K072245) | Cavex Holland BV | 2007-11-08 |
| SM INTERNAL./EXTERNAL IMPLANT SYSTEM (K070569) | Dio Department Dsi, Inc. | 2007-11-08 |
| GUNTHER TULIP VENA CAVA FILTER (K072240) | Cook, Inc. | 2007-11-08 |
| CONFORMIS UNI-CONDYLAR KNEE SYSTEM (K072586) | Conformis, Inc. | 2007-11-08 |
| AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C (K072359) | Aearo Company | 2007-11-08 |
| VITASCORE (K072014) | Vitascore B.V. | 2007-11-08 |
| CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET (K072960) | Cdp, Ltd. | 2007-11-08 |
| NEXFIX COMPRESSION PIN (K072710) | Nexa Orthopedics, Inc. | 2007-11-08 |
| PINNACLE PELVIC FLOOR REPAIR KITS (K071957) | Boston Scientific Corp | 2007-11-08 |
| COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM (K062264) | Medtronic Vascular | 2007-11-08 |
| STERICAN HYPODERMIC NEEDLES (K072247) | B.Braun Medical, Inc. | 2007-11-08 |
| UNICAPRONE (K072646) | United Medical Industries Co. , Ltd. | 2007-11-07 |
| MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY (K072956) | Derma Sciences, Inc. | 2007-11-07 |
| TENSION BAND ANTERIOR SPINAL SYSTEM (K071151) | Spinal Instrumentation Simplification Systems, LLC | 2007-11-07 |
| KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (K072135) | Kronus Market Development Associates, Inc. | 2007-11-07 |
| UNIGLACTIN (K072645) | United Medical Industries Co. , Ltd. | 2007-11-07 |
| ROYALE AE 9036 LSP INJECTOR (K073010) | Asico, LLC | 2007-11-07 |
| UNICRYL QUICK (K072644) | United Medical Industries Co. , Ltd. | 2007-11-07 |
| ASCA-CHEK (K071711) | Techlab Inc., Corporate Research Center | 2007-11-07 |
| 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. (K072423) | DePuy Orthopaedics, Inc. | 2007-11-07 |
| ISCALERT SENSOR SYSTEM (K071165) | Alertis Medical AS | 2007-11-07 |
| GENTIAN CYSTATIN C IMMUNOASSAY (K071388) | Gentian AS | 2007-11-06 |
| MEDSTREAMING MEDICAL OFFICE SOFTWARE (K072972) | Medstreaming, LLC | 2007-11-06 |
| AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (K071365) | C.R. Bard, Inc. | 2007-11-06 |
| MULTI-SPECT (K073021) | Eagle Heart Imaging, LLC | 2007-11-06 |
| AUSCO ES-3100 (K070550) | Koratek Company, Ltd. | 2007-11-06 |
| SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K072894) | Terumo Europe N.V. | 2007-11-06 |
| GS FIXTURE SYSTEM (K072896) | Osstem Implant Co., Ltd. | 2007-11-06 |
| ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE (K072430) | ZOLL Medical Corporation | 2007-11-06 |
| SMARTBLOCK PAIN PUMP (K072053) | Medical Flow Systems, Ltd. | 2007-11-06 |
| CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED (K072576) | Baxter Healthcare Corp | 2007-11-06 |
| THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS (K071692) | Theratest Laboratories, Inc. | 2007-11-05 |
| REGENEREX POROUS TITANIUM SLEEVE AUGMENTS (K072336) | Biomet Manufacturing Corp | 2007-11-05 |
| JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 (K072580) | Lang Dental Mfg. Co., Inc. | 2007-11-05 |
| AKITA2 APIXNEB (K072019) | Activaero America, Inc. | 2007-11-05 |
| V-CATH POLY PICC (K071875) | Hdc Corp. | 2007-11-05 |
| MEDIAID PULSE OXIMETER M30 AND M34 (K071610) | Mediaid, Inc. | 2007-11-05 |
| PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (K070270) | Kirchner & Wilhelm GmbH + Co.Kg | 2007-11-05 |
| BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (K072666) | Bio Compression Systems, Inc. | 2007-11-05 |
| GUMEASE DENTAL MOUTHPIECE (K072082) | Biomedevice , Ltd. | 2007-11-05 |
| NEXT GENERATION LASER (K062624) | Alcon Laboratories | 2007-11-05 |
| IMMULITE 2500 OM-MA, MODEL L5KOP (K072794) | Siemens Medical Solutions Diagnostics | 2007-11-05 |
| ACCOLADE II LASER (K072868) | Cynosure, Inc. | 2007-11-05 |
| ERBIUM FRACTIONAL HANDPIECE (K071768) | Palomar Medical Products, Inc. | 2007-11-05 |
| BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE (K072681) | Lifescience Plus, Inc. | 2007-11-02 |
| ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR (K070874) | Arthro Kinetics, Inc. | 2007-11-02 |
| TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M (K072532) | Dooyang Systems, Inc. | 2007-11-02 |
| ACTIVASCREW (K072848) | Bioretec, Ltd. | 2007-11-02 |
| AMPLATZER TORQVUE DELIVERY SYSTEM (K072313) | Aga Medical Corp. | 2007-11-02 |
| VENDYS, MODEL 6000 B B/C (K072919) | Endothelix, Inc. | 2007-11-02 |
| TEXTRONICS ECG ELECTRODE (K071576) | Textronics, Inc. | 2007-11-02 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (K070643) | Gambro, Inc. | 2007-11-02 |
| FRAXEL III SR LASER SYSTEM AND ACCESSORIES (K071051) | Reliant Technologies, Inc. | 2007-11-02 |
| SCHICK COMPUTED ORAL RADIOLOGY SYSTEM (K072134) | Schick Technologies, Inc. | 2007-11-02 |
| SPINEFRONTIER DORADO VBR (K072289) | Spinefrontier, Inc. | 2007-11-01 |
| MEGA SPINE SYSTEM (K072436) | Bk Meditech, Co., Ltd. | 2007-11-01 |
| IOL INJECTOR SET (K070669) | Medicel AG | 2007-11-01 |
| DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. (K072641) | Famidoc Technology Co., Ltd. | 2007-11-01 |