| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K071350) | Cardiovascular Systems, Inc. | 2007-08-22 |
| CORAL PEDICLE SCREW SYSTEM (K070962) | Theken Spine, LLC | 2007-08-22 |
| DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 (K063729) | Technomed Europe | 2007-08-21 |
| OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 (K070708) | Olympus Life & Material Science Europa GmbH (Irish | 2007-08-21 |
| PSS SYSTEM (K071438) | Spinal USA | 2007-08-21 |
| WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED (K071548) | Merz Dental GmbH | 2007-08-21 |
| MODEL 300D HOME OXYGEN LIQUEFIER (K071461) | Copd Partners, Inc. | 2007-08-21 |
| CONMED LINVATEC XO BUTTON (K070780) | Conmed Linvatec | 2007-08-21 |
| SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC (K063190) | Noble Fiber Technologies, Inc. | 2007-08-21 |
| TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 (K070185) | Pharos Life Corporation | 2007-08-21 |
| TITANIUM HIP TOOL LOCKING PLATE (K072175) | Orthopedic Sciences, Inc. | 2007-08-21 |
| SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) (K070981) | Aesculap Implant Systems, Inc. | 2007-08-21 |
| FORU KV10HB (K072027) | Kwang Yang Motor Co., Ltd. | 2007-08-20 |
| ARTHREX UNIVERS II SHOULDER PROSTHESIS (K071032) | Arthrex, Inc. | 2007-08-20 |
| CONMED LINVATEC 300W XENON LIGHT SOURCE (K070376) | Conmed Linvatec | 2007-08-20 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN (K071317) | Dade Behring, Inc. | 2007-08-20 |
| MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM (K071380) | Alphatec Spine, Inc. | 2007-08-20 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML (K071623) | Becton, Dickinson & CO | 2007-08-20 |
| CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 (K072096) | R&D Systems, Inc. | 2007-08-20 |
| URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 (K071822) | Uroplasty, Inc. | 2007-08-20 |
| R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 (K071361) | R4 Vascular, Inc. | 2007-08-20 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN (K071316) | Dade Behring, Inc. | 2007-08-20 |
| ROOT ZX II (K071190) | J. Morita USA, Inc. | 2007-08-17 |
| DEPUY GCK TIBIAL COMPONENTS (K070267) | DePuy Orthopaedics, Inc. | 2007-08-17 |
| INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP (K071669) | Integra Radionics, Inc. | 2007-08-17 |
| NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F (K070970) | Penumbra, Inc. | 2007-08-17 |
| GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM (K071790) | Smith & Nephew, Inc. | 2007-08-17 |
| REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES (K070036) | Ascent Healthcare Solutions | 2007-08-17 |
| SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE (K071404) | Power Products, Inc.-Splintek | 2007-08-17 |
| BIORAPTOR 2.3 PK SUTURE ANCHOR (K071586) | Smith & Nephew Inc., Endoscopy Division | 2007-08-17 |
| ARTHROCARE SPINEWAND (K072089) | Arthrocare Corp. | 2007-08-17 |
| DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS (K071518) | B. Braun Medizintechnologie GmbH | 2007-08-17 |
| HEARTWAY POWER MOBILITY SCOOTER, PF6 (K072104) | Heartway Medical Products Co., Ltd. | 2007-08-17 |
| M3 MONITOR (K072131) | Spectrum Medical , Ltd. | 2007-08-17 |
| QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V (K072060) | Nihon Kohden America, Inc. | 2007-08-17 |
| STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM (K071834) | Dade Behring, Inc. | 2007-08-17 |
| EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 (K071320) | Everlife Medical Equipment Co., Ltd. | 2007-08-17 |
| BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER (K070002) | Boston Scientific | 2007-08-17 |
| REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (K070034) | Ascent Healthcare Solutions | 2007-08-17 |
| VICTORY THREE WHEEL SCOOTER, MODEL: SC610 (K072165) | Pride Mobility Products Corp. | 2007-08-17 |
| GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND (K071985) | General Electric Co. | 2007-08-17 |
| VITRIFREEZE MEDIUM; VITRITHAW MEDIUM (K070135) | Fertipro NV | 2007-08-16 |
| CRYOSEAL FS APPLICATOR SYSTEM (K071126) | Thermogenesis Corp. | 2007-08-16 |
| REBOUND HRD (K063671) | Minnesota Medical Development, Inc. | 2007-08-16 |
| COMCASET-P SAFETY IV CATHETER (K070020) | Pitango Medical, Ltd. | 2007-08-16 |
| B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES (K071459) | B.Braun Medical, Inc. | 2007-08-16 |
| RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 (K063836) | Medtronic Neurosurgery | 2007-08-16 |
| INSIGHT DISCOVERY (K063447) | Fasstech | 2007-08-16 |
| XEBRA DICOM IMAGE BROWSER (K071894) | Hx Technologies, Inc. | 2007-08-16 |
| MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K071308) | Neusoft Medical Systems Co., Ltd. | 2007-08-16 |
| VENDYS MODEL 5000 B/BC (K060980) | Endothelix, Inc. | 2007-08-16 |
| ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (K061880) | Isotis NV | 2007-08-15 |
| BEAUTIFIL II (K071742) | Shofu Dental Corp. | 2007-08-15 |
| MODIFICATION TO SCORPIO NRG KNEE SYSTEM (K071991) | Howmedica Osteonics Corp. | 2007-08-15 |
| ARGEN PEARL BRAND ZIRCONIA (K071410) | The Argen Corporation | 2007-08-15 |
| INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM (K071469) | Candela Corp. | 2007-08-15 |
| REVERTO 55 AND 37 SHAPE MEMORY STAPLES (K071477) | Core Essence Orthopaedics, LLC | 2007-08-15 |
| HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) (K071992) | Varian Medical Systems | 2007-08-15 |
| CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) (K071682) | Alara, Inc. | 2007-08-15 |
| CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM (K071138) | Prosurg, Inc. | 2007-08-15 |
| STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS (K072071) | Institut Straumann AG | 2007-08-15 |
| SPECTROLYSE PAI-1, MODEL 101201 (K063323) | American Diagnostica, Inc. | 2007-08-15 |
| MINI TIGHTROPE FT REPAIR KIT (K071978) | Arthrex, Inc. | 2007-08-15 |
| APEX HCLA ACETABULAR CUP LINERS (K062489) | Omnilife Science | 2007-08-15 |
| HEMOSIL RECOMBIPLASTIN 2G (K070005) | Instrumentation Laboratory CO | 2007-08-15 |
| HEATMARKER TIME TEMPERATURE INDICATOR (K063759) | Temptime Corporation | 2007-08-15 |
| LANX DEFORMITY SYSTEM (K071633) | Lanx, LLC | 2007-08-15 |
| KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K070828) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2007-08-15 |
| ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE (K071756) | Pointe Conception Medical, Inc. | 2007-08-15 |
| INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER (K070151) | Ethicon Endo-Surgery, LLC | 2007-08-15 |
| EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER (K071738) | Exactech, Inc. | 2007-08-15 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072001) | Tangshan Hongyun Plastic Products Co., Ltd. | 2007-08-15 |
| AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 (K071699) | Aga Medical Corp. | 2007-08-15 |
| MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 (K070023) | Microsurgeon, Inc. | 2007-08-15 |
| BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS (K071266) | Bausch & Lomb, Inc. | 2007-08-15 |
| ICATH, STERILESURE (K071496) | Colorado Catheter Company, Inc. | 2007-08-15 |
| KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR (K070826) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2007-08-15 |
| MAGNETOM ESSENZA (K071925) | Siemens Medical Solutions USA, Inc. | 2007-08-14 |
| PTFE FLIXENE GRADUATED WALL GRAFT (K071923) | Atrium Medical Corp. | 2007-08-14 |
| BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (K071710) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| GRAFTLOCK SCREW, ST SCREW (K071952) | Biocomposites, Ltd. | 2007-08-14 |
| T2 XVBR SPINAL SYSTEM (K071033) | Medtronic Sofamor Danek | 2007-08-14 |
| NEOGUIDE ENDOSCOPY SYSTEM (K070622) | Neoguide Systems, Inc. | 2007-08-14 |
| 1.3M MONOCHROME LCD MONITOR MDL1908A (K072066) | Totoku Electric Co., Ltd. | 2007-08-14 |
| IGUIDE SYSTEM (K072079) | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2007-08-14 |
| MASTERSCREEN PNEUMO & MASTERSCOPE (K071753) | Viasys Healthcare GmbH | 2007-08-14 |
| 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) (K072065) | Totoku Electric Co., Ltd. | 2007-08-14 |
| FINGERTIP PULSE OXIMETER MD300C (K070371) | Beijing Choice Electronic Technololgy Co., Ltd. | 2007-08-13 |
| IFS BONE FIXATION DEVICES (K071035) | Internal Fixation Systems, Inc. | 2007-08-13 |
| TESLA NIBP (K062974) | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007-08-13 |
| MODIFICATION TO SOLAR GI (K071094) | Medical Measurement Systems B.V. | 2007-08-13 |
| STD MED PRIMO PORT (K070911) | Std Med, Inc. | 2007-08-10 |
| SERENITY PRO PSF SYSTEM (K071943) | Inolase 2002, Ltd. | 2007-08-10 |
| SELF-LIGHT DISPOSABLE ANOSCOPE (K070913) | Sapimed S.P.A. | 2007-08-10 |
| NANO-BOND II ADHESIVE SYSTEM (K071500) | Pentron Clinical Technologies | 2007-08-10 |
| CAMLOG LOGFIT PROSTHETIC SYSTEM (K071213) | Altatec GmbH | 2007-08-10 |
| PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS (K072070) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-08-10 |
| MEMO 3D SEMIRIGID ANNULOPLASTY RING (K071327) | Sorin Biomedica Cardio S.R.L. | 2007-08-10 |
| ENDOWAVE INFUSION SYSTEM (K071933) | Ekos Corp. | 2007-08-10 |
| DEEP BLUE (K071722) | E.M.S Electro Medical Systems S.A | 2007-08-10 |