| SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING (K081229) | Smiths Medical Asd, Inc. | 2008-07-21 |
| NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (K081515) | Neomed, Inc. | 2008-07-21 |
| SONICWELD RX (RESORB-X) (K080862) | KLS-Martin L.P. | 2008-07-21 |
| BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST (K081218) | It-V Medizintechnik, GmbH | 2008-07-21 |
| AG-605 BLOOD GLUCOSE MONITORING SYSTEM (K073030) | Andon Health Co, Ltd. | 2008-07-21 |
| MODIFICATION TO MAMMAPRINT (K080252) | Agendia BV | 2008-07-21 |
| CAM STRUCTSURE PRECISION MILLED BARS (K080864) | Biomet 3i, Inc. | 2008-07-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) (K081655) | Jiangsu Cureguard Glove Co., Ltd. | 2008-07-21 |
| RAMP NT-PROBNP ASSAY (K063662) | Response Biomedical Corp. | 2008-07-21 |
| STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K081719) | Stanbio Laboratory | 2008-07-18 |
| SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM (K081452) | Synthes (Usa) | 2008-07-18 |
| MODIFIED HD GUIDE CATHETER (K080583) | Concentric Medical, Inc. | 2008-07-18 |
| CADD MEDICATION CASSETTE RESERVOIR (K081156) | Smiths Medical MD, Inc. | 2008-07-18 |
| SIALO DRAIN (K072334) | Sialo Technology, Ltd. | 2008-07-18 |
| SIMPLANT ORTHO ; VISTADENT 3D (K081402) | Materialise Dental NV | 2008-07-18 |
| VARIAX DISTAL FIBULA PLATE (K081284) | Howmedica Osteonics Corp. | 2008-07-18 |
| MERETE 3.0 AND 3.5 MM LOCKING SCREWS (K081513) | Merete Medical GmbH | 2008-07-18 |
| HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES (K081061) | Harvard Medical Devices , Ltd. | 2008-07-18 |
| ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (K080067) | Iscience Interventional | 2008-07-18 |
| WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES (K080465) | Ws Far IR Medical Technology Co., Ltd. | 2008-07-18 |
| AOC SOLUBLE IMPLANT MATERIAL (K081531) | Ceremed , Inc. | 2008-07-18 |
| CINCH ANCHOR, MODEL 1194 (K081208) | Advanced Neuromodulation Systems | 2008-07-18 |
| CHROMOLITE EP (K081619) | Chromogenex Technologies Limited | 2008-07-18 |
| PIGALILEO 4TH GENERATION SYSTEM (K080875) | Smith & Nephew, Inc. | 2008-07-18 |
| STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE (K081512) | Medtronic Navigation, Inc. | 2008-07-18 |
| PROGENIX PLUS (K081950) | Medtronic Sofamor Danek, Inc. | 2008-07-18 |
| ASPIRA PERITONEAL DRAINAGE SYSTEM (K081288) | C.R. Bard, Inc. | 2008-07-18 |
| APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125) | Wako Chemicals USA, Inc. | 2008-07-18 |
| BLOOD TUBING SETS (STERILE FLUID PATH) (K080807) | Nxstage Medical, Inc. | 2008-07-18 |
| SINTEA BIOTECH PLS MULTI-AXIAL SCREWS (K081631) | Sintea Biotech, Inc. | 2008-07-18 |
| BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 (K081446) | Becton, Dickinson & CO | 2008-07-17 |
| AEQUALIS REVERSED SHOULDER PROSTHESIS (K081059) | Tornier | 2008-07-17 |
| MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) (K080878) | Medical Technologies of Georgia, Inc. | 2008-07-17 |
| PRECISION FLOW (K072845) | Vapotherm, Inc. | 2008-07-17 |
| PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE (K080731) | Osyris | 2008-07-17 |
| SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION (K081700) | Synthes (Usa) | 2008-07-17 |
| AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS (K081707) | Tornier, Inc. | 2008-07-17 |
| VISENSIA (K081140) | Obs Medical | 2008-07-17 |
| APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (K080123) | Wako Chemicals USA, Inc. | 2008-07-17 |
| HG II FIXTURE SYSTEM (K080744) | Osstem Implant Co., Ltd. | 2008-07-17 |
| PATHWAY PV ATHERECTOMY SYSTEM (K081328) | Pathway Medical Technologies, Inc. | 2008-07-17 |
| STRYKER POWER TOOL NAVIGATOR ATTACHMENT (K080450) | Stryker Corp. | 2008-07-17 |
| ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (K073720) | Osmetech Molecular Diagnostics | 2008-07-17 |
| COMPOSITE HITCH SUTURE ANCHOR (K081172) | Biomet Manufacturing Corp | 2008-07-17 |
| ADVIA CENTAUR HAVM ASSAY (K081716) | Siemens Healthcare Diagnostics, Inc. | 2008-07-17 |
| ENDOBUTTON CONTINUOUS LOOP (CL) (K081098) | Smith & Nephew Inc., Endoscopy Division | 2008-07-16 |
| PRE-VA VAGINAL LUBRICANT (K072741) | Ingfertility, LLC | 2008-07-16 |
| LION SE ONE STEP ORTHODONTIC ADHESIVE (K080445) | Classone Orthodontics, Inc. | 2008-07-16 |
| QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI (K080905) | Quantum Medical Imaging, LLC | 2008-07-16 |
| AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (K081841) | Amplivox, Ltd. | 2008-07-16 |
| EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE (K081873) | Shenzhen Emperor Electronic Technology Co. , Ltd. | 2008-07-16 |
| DIAZYME APOLIPOPROTEIN A-1 ASSAY (K072977) | General Atomics | 2008-07-16 |
| ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905) | Westmed, Inc. | 2008-07-15 |
| ULTRASONIC NEBULISER MODEL 2010 (K072136) | Wilfred Kromker GmbH | 2008-07-15 |
| SCREWINDIRECT DENTAL IMPLANTS (K080633) | Implant Direct, LLC | 2008-07-15 |
| FENCER 308 EXCIMER LASER SYSTEM (K080975) | Kera Harvest/Laser Max Medical Technologies Corp | 2008-07-15 |
| ULTRASHARP CONCENTRIC NEEDLES (K080914) | Rochester Electro Medical, Inc. | 2008-07-15 |
| ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 (K081843) | Aloka Co., Ltd. | 2008-07-15 |
| VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K080897) | Talley Medical | 2008-07-15 |
| NT/IT SYSTEM (K081078) | Osstem Implant Co., Ltd. | 2008-07-15 |
| ORTHOMESH (K073115) | Synthes (Usa) | 2008-07-15 |
| ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K081389) | Roche Diagnostics | 2008-07-15 |
| MAC 1600 ECG ANALYSIS SYSTEM (K081437) | Ge Medical Systems Information Technologies | 2008-07-15 |
| KUMAR T-ANCHORS HERNIA SET (K081366) | Nashville Surgical Instruments | 2008-07-15 |
| TEPHAFLEX ABSORBABLE SUTURE (K081099) | Tepha, Inc. | 2008-07-15 |
| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (K081690) | Cook, Inc. | 2008-07-14 |
| TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE (K081188) | Varian Medical Systems, Inc. | 2008-07-14 |
| GN OTOMETRICS INSERT EARPHONES (K081234) | Gn Otometrics | 2008-07-14 |
| KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM (K081089) | Kimberly-Clark Corp. | 2008-07-14 |
| MONOPOLY PEDICLE SCREW SYSTEM (K081108) | Signus Medical, LLC | 2008-07-14 |
| SPINAL ELEMENTS BUTTRESS PLATE SYSTEM (K081418) | Spinal Elements, Inc. | 2008-07-14 |
| CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR (K072291) | Conmed Linvatec | 2008-07-14 |
| S40 CLINICAL ANALYZER, S TEST ALB (K072143) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-07-14 |
| STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS (K080982) | Boston Scientific Corp | 2008-07-14 |
| SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM (K081132) | Spine Smith Partners L.P. | 2008-07-14 |
| ICI P AND S SERIES IR CAMERAS (K073581) | Texas Infrared | 2008-07-11 |
| CX50 DIAGNOSTIC ULTRASOUND SYSTEM (K081802) | Philips Ultrasound, Inc. | 2008-07-11 |
| MODIFICATION TO XYLOS SURGICAL MESH (K081882) | Xylos Corporation | 2008-07-11 |
| CARDIOSEN'C (K080047) | Shl Telemedicine International , Ltd. | 2008-07-11 |
| HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS (K080666) | MicroVention, Inc. | 2008-07-11 |
| SOPRO 670 ARTHROSCOPIC PUMP (K080122) | Sopro | 2008-07-11 |
| SRT II MUSCLE STIMULATOR (K071677) | Therapeutic Innovations, Inc. | 2008-07-11 |
| SERIM DISINTEK OPA TEST STRIP (K081370) | Serim Research Corp. | 2008-07-11 |
| INION SPINAL GRAFT CONTAINMENT SYSTEM (K071810) | Inion , Ltd. | 2008-07-11 |
| INSULIN PROTECTOR (K073555) | Medicool, Inc. | 2008-07-11 |
| CAPIMAGE (K081829) | Danish Diagnostic Development A/S | 2008-07-11 |
| KEY LASER III 1243 US WITH DETECT (K073074) | Kavo America | 2008-07-10 |
| VARIOSURG (K073678) | Nakanishi, Inc. | 2008-07-10 |
| WELL LEAD REINFORCED ENDOTRACHEAL TUBE (K073383) | Well Lead Medical Instruments | 2008-07-10 |
| AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (K081345) | Thermogenesis Corp. | 2008-07-10 |
| IMPROVED COMFORT-FIT NIGHTGUARD (K081669) | Den Tek Oral Care, Inc. | 2008-07-10 |
| ENSPLINT TM BONE SCREW (K080778) | Sonoma Orthopedic Products, Inc. | 2008-07-10 |
| MODEL 7340 ULTRASOUND SYSTEM (K081794) | Esaote, S.p.A. | 2008-07-10 |
| NUCLEUS-X, MODEL 230X (K081680) | NuMED, Inc. | 2008-07-10 |
| ULTRACAPS S (K081273) | Sdi , Ltd. | 2008-07-10 |
| WATER WORKS DOUCHING DEVICE (K080200) | Abbott Research Group, Inc. | 2008-07-10 |
| LIPO CANNULA (K081039) | Millennium Medical Technologies, Inc. | 2008-07-10 |
| ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739) | Abbott Molecular, Inc. | 2008-07-10 |
| GENEX PUTTY (K073341) | Biocomposites, Ltd. | 2008-07-09 |
| HUMIDAIRE 2I (K080797) | Resmed, Ltd. | 2008-07-09 |