| S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA (K080968) | Esaote, S.p.A. | 2008-04-29 |
| SMARTSPOT PRIMAX (K080890) | Cmt Medical Technologies, Ltd. | 2008-04-29 |
| TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS (K080871) | Nucletron Corporation | 2008-04-29 |
| ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL (K080317) | Syntheon, LLC | 2008-04-29 |
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |
| TRANSPOSAL ULTRA SYSTEMS (K081047) | Dornoch Medical Systems, Inc. | 2008-04-29 |
| MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM (K080790) | Theken Spine, LLC | 2008-04-29 |
| KODAK 9000C EXTRAORAL IMAGING SYSTEM (K080889) | Trophy | 2008-04-29 |
| FOX PLUS PTA CATHETER (K080925) | Abbott Vascular, Inc. | 2008-04-28 |
| NACERA Z AND NACERA Z MEDIUM (K080195) | Doceram Medical Ceramics GmbH | 2008-04-28 |
| RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA (K071867) | Paragondx, LLC | 2008-04-28 |
| AESCULAP PRIMELINE CONTAINER LTD. (K073168) | Aesculap, Inc. | 2008-04-28 |
| CAP PLUS, EQUIVABONE, CAP/DBM (K080329) | Etex Corp. | 2008-04-28 |
| TRANS1 AXIALIF 2-LEVEL OR II SYSTEM (K073643) | Trans1 Incorporated | 2008-04-28 |
| MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION (K080885) | Medacta International S.A. | 2008-04-28 |
| NEUROMETRIX ADVANCE (K070109) | Neurometrix, Inc. | 2008-04-25 |
| PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING (K071552) | Medline Industries, Inc. | 2008-04-25 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 (K080151) | Angioscore, Inc. | 2008-04-25 |
| PC ECG 1200W SYSTEM (K080141) | Norav Medical , Ltd. | 2008-04-25 |
| IFS LASER SYSTEM (K073404) | Intra Lase Corp. | 2008-04-25 |
| PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 (K073356) | Medtronic Minimed | 2008-04-25 |
| INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (K072932) | Infraredx, Inc. | 2008-04-25 |
| COMFORTGEL FULL FACE MASK (K073600) | Respironics Inc., Sleep & Home Respiratory Group | 2008-04-25 |
| MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM (K080690) | Theken Spine, LLC | 2008-04-25 |
| EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD (K080408) | Advanced Orthopaedic Solutions, Inc. | 2008-04-25 |
| SIGNA 3.0T MR750 SYSTEM (K081028) | Ge Medical Systems, LLC | 2008-04-25 |
| ACUSON X300 ULTRASOUND SYSTEM (K080760) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-04-25 |
| MODIFICATION TO VF GEL PLUS (K080956) | Coapt Systems, Inc. | 2008-04-25 |
| LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP (K080743) | Smiths Medical MD, Inc. | 2008-04-25 |
| LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A (K073358) | Heeyoung Co., Ltd. | 2008-04-25 |
| SYNGO DYNAMICS VERSION 7.0 (K081018) | Siemens Medical Solutions | 2008-04-25 |
| ZOLL E SERIES DEFIBRILLATOR (K072923) | Zoll Medical Corporation, World Wide Headquarters | 2008-04-24 |
| SURGI GLOVES (K073447) | Metacure Surgical Gloves Sdn Bhd | 2008-04-24 |
| CR-1 (K080883) | Canon, Inc. | 2008-04-24 |
| PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A (K080627) | Promedical Products Co., Ltd. | 2008-04-24 |
| ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (K073640) | Axis-Shield Diagnostics, Ltd. | 2008-04-24 |
| FOUNDATION CAGE (K073440) | Corelink, LLC | 2008-04-24 |
| CAPSTONE SPINAL SYSTEM (K073291) | Medtronic Sofamor Danek USA, Inc. | 2008-04-24 |
| MEDDORNA WIRELESS PRN SPIROMETER 100 (K072722) | Meddorna, LLC | 2008-04-24 |
| TARGET STERILE ELECTRODE (K072799) | Vision Quest Industries, Inc. | 2008-04-24 |
| FAST1 INTRAOSSEOUS INFUSION SYSTEM (K080865) | Pyng Medical Corp. | 2008-04-24 |
| ERCHONIA EML LASER (K072206) | Erchonia Medical, Inc. | 2008-04-24 |
| SAFETY INFUSION SET (K080235) | Greiner Bio-One Vacuette North America | 2008-04-24 |
| ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (K080838) | Alveolus, Inc. | 2008-04-24 |
| SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 (K080005) | Ding Hwa Co., Ltd. | 2008-04-24 |
| DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY (K080315) | Derma Sciences, Inc. | 2008-04-23 |
| DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 (K080918) | Depuy Mitek | 2008-04-23 |
| CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 (K080425) | Biosense Webster, Inc. | 2008-04-23 |
| TOSCA II ANTERIOR CERVICAL PLATE SYSTEM (K080815) | Signus Medizintechnik GmbH | 2008-04-23 |
| PLLA, HA SCREW (K080358) | Smith & Nephew Inc., Endoscopy Div. | 2008-04-23 |
| ZOLL E SERIES 12SL, ANALYSIS OPTION (K080232) | Zoll Medical Corporation, World Wide Headquarters | 2008-04-23 |
| AMBULO 2400 (K080274) | Tiba Medical, Inc. | 2008-04-23 |
| ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL (K073547) | Anacapa Technologies, Inc. | 2008-04-23 |
| CENTURION SORBAVIEW OTC (K080524) | Tri-State Hospital Supply Corp. | 2008-04-23 |
| SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES (K080248) | Lutronic Corporation | 2008-04-23 |
| SEDAT MYSHELL LITE (K080472) | Sedat | 2008-04-23 |
| MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K080670) | Atcor Medical | 2008-04-23 |
| TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM (K080335) | Tornier, Inc. | 2008-04-23 |
| SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS (K080943) | Synthes (Usa) | 2008-04-23 |
| ELTA ADVANCED WOUND WASH (K073610) | Swiss American Products, Inc. | 2008-04-23 |
| QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) (K080985) | Surgical Specialties Corp | 2008-04-23 |
| ELIPO (K073715) | Syneron Medical, Ltd. | 2008-04-23 |
| PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C (K080174) | Cardio Med Supplies, Inc. | 2008-04-23 |
| MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE (K080821) | Kimberly-Clark Corp. | 2008-04-22 |
| UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT (K080162) | Mis Implants Technologies , Ltd. | 2008-04-22 |
| PERIPHERAL NERVE BLOCK SUPPORT TRAY (K073187) | Life-Tech, Inc. | 2008-04-22 |
| MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (K072061) | Viasys Healthcare GmbH | 2008-04-22 |
| WESTCON HORIZON 49% (HIOXIFILCON B) (K080686) | Westcon Contact Lens Co. | 2008-04-22 |
| ENDOWAVE INFUSION SYSTEM (K073166) | Ekos Corp. | 2008-04-22 |
| DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI (K080351) | Dexela, Ltd. | 2008-04-22 |
| SYNGO MULTIMODALITY WORKPLACE (K072728) | Siemens AG Medical Solutions | 2008-04-22 |
| CUTTERSIL ACTIVATOR UNIVERSAL PLUS (K080338) | Heraeus Kulzer,GmbH | 2008-04-21 |
| SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 (K080501) | Taidoc Technology Corporation | 2008-04-21 |
| MARIONETTE SA, MODEL 001 001 & 001 002 (K072811) | Kinetic Surgical, LLC | 2008-04-21 |
| PLEXUR-P (K080511) | Osteotech, Inc. | 2008-04-21 |
| GRAVILAX TRACTION SYSTEM (K072064) | Therapeutic Clinical Technologies, Inc. | 2008-04-21 |
| REGENEREX TIBIAL COMPONENTS (K080361) | Biomet, Inc. | 2008-04-21 |
| AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT (K080507) | Ceremed , Inc. | 2008-04-21 |
| DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE (K072613) | Micro Invasive Technology, Inc. | 2008-04-21 |
| CELL GEN LASER, MODEL CG-4000 (K080084) | Cell Gen Therapeutics, LLC | 2008-04-21 |
| MODIFICATION TO ENDOFAST RELIANT SYSTEM (K080836) | Endogun Medical Systems | 2008-04-21 |
| CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (K072548) | Teco Diagnostics | 2008-04-18 |
| ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM (K073231) | Lifescan, Inc. | 2008-04-18 |
| HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM (K073269) | Hypnocore, Ltd. | 2008-04-18 |
| FCR GO PORTABLE DIGITAL X-RAY SYSTEM (K080945) | Fujifilm Medical Systems U.S.A, Inc. | 2008-04-18 |
| 50W CERALAS D 1950NM DIODE LASER (K072682) | Biolitec, Inc. | 2008-04-18 |
| MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM (K080311) | Dentsply Interntional | 2008-04-18 |
| MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K080805) | Medtronic Sofamor Danek | 2008-04-18 |
| 3TEST SUPREME GLUCOSE MONITORING SYSTEM (K072905) | Neuero Engineering, Inc. | 2008-04-18 |
| NM APPLICATION SUITE (K080961) | Philips Nuclear Medicine, Inc. | 2008-04-18 |
| AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM (K080757) | Aga Medical Corp. | 2008-04-18 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM (K072714) | Roche Diagnostics Corp. | 2008-04-18 |
| YULEX LATEX POWDER-FREE EXAM GLOVES (K063810) | Yulex Corporation | 2008-04-18 |
| VARIOS 75 (K071447) | Nakanishi, Inc. | 2008-04-18 |
| ISOBAR SEMI-RIGID DUAL DAMPENER (K071261) | Scient'X | 2008-04-17 |
| BIOMOVE 5000 SYSTEM (K080787) | Curatronic, Ltd. | 2008-04-17 |
| INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM (K073690) | Interlace Medical, Inc. | 2008-04-17 |
| INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 (K073585) | Vascular Solutions, Inc. | 2008-04-17 |
| K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K080070) | Grace Medical, Inc. | 2008-04-17 |
| TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE (K080863) | MicroVention, Inc. | 2008-04-17 |