| TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL (K091114) | Quality Electrodynamics | 2009-05-01 |
| XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 (K090303) | Corespine Technologies, LLC | 2009-04-30 |
| SYNTHES 90 DEGREE SCREWDRIVER (K082649) | Synthes (Usa) | 2009-04-30 |
| SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE (K090556) | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009-04-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 (K090963) | Andon Health Co, Ltd. | 2009-04-30 |
| COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D (K090171) | E-Woo Technology | 2009-04-30 |
| MODIFICATION TO AUTOFUSER (K090300) | Ace Medical Us, LLC | 2009-04-30 |
| GE DATEX-OHMEDA S/5 ADU CARESTATION (K090892) | GE Healthcare Finland Oy | 2009-04-30 |
| IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM (K090059) | Saset (Chengdu), Inc. | 2009-04-30 |
| GENADYNE A4-XLR8 WOUND VACUUM SYSTEM (K090638) | Genadyne Biotechnologies, Inc. | 2009-04-29 |
| ROC LUMBAR PLATING SYSTEM (K090228) | Alphatec Spine, Inc. | 2009-04-29 |
| COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS (K082363) | William A. Cook Australia Pty. , Ltd. | 2009-04-29 |
| DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID (K090594) | Siemens Healthcare Diagnostics | 2009-04-29 |
| EMPRESS DIRECT (K090701) | Ivoclar Vivadent, Inc. | 2009-04-29 |
| OPAL SEAL (K090355) | Ultradent Products, Inc. | 2009-04-29 |
| MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS (K091084) | Cotton High Tech S.L. | 2009-04-29 |
| PRIMADO (K083112) | Nakanishi, Inc. | 2009-04-29 |
| CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 (K091017) | Cardica, Inc. | 2009-04-29 |
| MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 (K090569) | 3M Company | 2009-04-29 |
| I-FIX SYSTEM (K083586) | Dentis Co., Ltd. | 2009-04-29 |
| MTA PROTECTIVE SHEET (K090778) | Xylos Corporation | 2009-04-28 |
| TRAXODENT (K083695) | Premier Dental Products Co. | 2009-04-28 |
| PIONEER LUMBAR PLATE SYSTEM (K090222) | Pioneer Surgical Technology | 2009-04-28 |
| SYNGO BREVIS (K090038) | Siemens Medical Solutions USA, Inc. | 2009-04-28 |
| SWABCAP (K083508) | Excelsior Medical Corp. | 2009-04-28 |
| BCI WW1021 PC APPLICATION (K090205) | Smiths Medical Pm, Inc. | 2009-04-28 |
| HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM (K083203) | Laseroptek Co., Ltd. | 2009-04-28 |
| MPS ACACIA POWER INJECTABLE INFUSION SET (K090809) | Mps Acacia | 2009-04-28 |
| CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V (K082038) | Clarus Medical, LLC | 2009-04-28 |
| ORTHOSTAT (K091121) | Orthocon, Inc. | 2009-04-28 |
| DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (K090236) | Siemens Healthcare Diagnostics | 2009-04-27 |
| ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER (K090822) | Cook, Inc. | 2009-04-27 |
| ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE (K090905) | B.Braun Medical, Inc. | 2009-04-27 |
| STEERABLE GUIDE CATHETER (K083793) | Evalve, Inc. | 2009-04-27 |
| SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE (K083931) | Quantum Co., Ltd. | 2009-04-27 |
| DS N95 SURGICAL MASKS AND FLAT SURGICAL (K090131) | Shanghai Dasheng Health Products | 2009-04-27 |
| NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM (K090176) | Nuvasive, Inc. | 2009-04-27 |
| STRYKER SPINE AVS PL PEEK SPACERS (K090816) | Stryker Corp. | 2009-04-24 |
| SKLAR SURGICAL GOWN (K082479) | Sklar Corp. | 2009-04-24 |
| ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 (K090178) | Neusoft Positron Medical Systems Co., Ltd. | 2009-04-24 |
| MOBILECARE MONITOR, MODEL 2100 (K090138) | Aframe Digital, Inc. | 2009-04-24 |
| NOVAGUARD, MODEL 3611001 (K082908) | West Pharmaceutical Services, Inc. | 2009-04-24 |
| CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM (K090185) | Taidoc Technology Corporation | 2009-04-24 |
| MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS (K090839) | Syntec Scientific Corp. | 2009-04-24 |
| PEDIPLATES (K090666) | OrthoPediatrics Corp. | 2009-04-24 |
| LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA (K083509) | Genx Intl., Inc. | 2009-04-24 |
| PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P (K083351) | Comdek Industrial Corp. | 2009-04-24 |
| BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS (K090299) | Aesculap Implant Systems | 2009-04-24 |
| BILI BLUE F20T12/BBY AND F40T12/BBY (K090192) | Interlectric Corp. | 2009-04-24 |
| APTUS 2.0 RADIAL HEAD SYSTEM (K090053) | Medartis AG | 2009-04-23 |
| REBOUND HRDV (K083467) | Minnesota Medical Development, Inc. | 2009-04-23 |
| EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM (K082934) | Extremity Medical, LLC | 2009-04-23 |
| CLUE MEDICAL AND CLUE MEDICAL BASIC (K083630) | Telovital GmbH Telemedizin | 2009-04-23 |
| FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY (K083889) | Fotona D.D. | 2009-04-23 |
| DINKLER SURGICAL SKULL CLAMP, MODEL 0308 (K090695) | Dinkler Surgical Devices, Inc. | 2009-04-23 |
| BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (K090464) | Pt Mahakarya Inti Buana | 2009-04-23 |
| WALGREEN'S PERSONAL LUBRICATING JELLY (K080978) | Topco Sales | 2009-04-23 |
| BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 (K090217) | Coloplast A/S | 2009-04-23 |
| MERETE LOCKING BONE PLATE SYSTEM (K090063) | Merete Medical, Inc. | 2009-04-22 |
| YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB (K090058) | Ya Horng Electronic Co., Ltd. | 2009-04-22 |
| APEX MEDICAL XT AUTO CPAP 9S-005200 (K083656) | Apex Medical Corp. | 2009-04-22 |
| WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM (K083374) | Boston Scientific Corp | 2009-04-22 |
| INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (K090070) | Invuity, Inc. | 2009-04-22 |
| SPEC MODEL M-31 (K090366) | Source Production & Equipment Co., Inc. | 2009-04-22 |
| ULTIMUM/ENGAGE/ENGAGE TR (K091137) | St Jude Medical | 2009-04-22 |
| BLOOD MONITORING UNIT, MODEL BMU 40 (K090147) | Maquet Cardiopulmonary, AG | 2009-04-22 |
| NOVEL ALIF SPINAL SPACER SYSTEM (K090782) | Alphatec Spine, Inc. | 2009-04-22 |
| FLUID-FILLED TEETHER (K083512) | Wiltec Industries , Ltd. | 2009-04-22 |
| AVS ANTERIOR LARGE PEEK SPACERS (K090166) | Stryker Corp. | 2009-04-22 |
| HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS (K090074) | Hygia Health Services, Inc. | 2009-04-22 |
| MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K091087) | Surgical Devices, Tyco Healthcare Group LP | 2009-04-22 |
| BLUE SKY BIO PLAN, VERSION .38 (K090607) | Blue Sky Bio, LLC | 2009-04-22 |
| MODIFICATION TO EXPEDIUM SPINE SYSTEM (K090799) | Depuy Spine, Inc. | 2009-04-22 |
| FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 (K090116) | Fujinon, Inc. | 2009-04-22 |
| BARCO 5MP MAMMO, MODEL MDMG-5221 (K090603) | Barco N.V. | 2009-04-22 |
| PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (K091011) | Surgical Technology Laboratories, Inc ("Stl") | 2009-04-22 |
| NOVATION CFS PRESS-FIT AND CEMENTED STEMS (K090764) | Exactech, Inc. | 2009-04-21 |
| APEXUM ABLATOR (K082325) | Apexum , Ltd. | 2009-04-21 |
| MECC SET WITH BIOLINE COATING (K083794) | Maquet Cardiopulmonary, AG | 2009-04-21 |
| ONE STEP HCG URINE/SERUM TEST (K072500) | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 |
| INTRAVENOUS POWER INJECTOR EXTENSION SET (K090134) | C.R. Bard, Inc. | 2009-04-21 |
| NEUTROLUMENPN SYSTEM, MODEL 1000 (K082223) | Neurolumen, LLC | 2009-04-21 |
| CHEMPAQ XBC ANALYZER (K090013) | Chempaq A/S | 2009-04-21 |
| TENS/NMES/FES STIMULATING ELECTRODE (K083350) | Covidien LP | 2009-04-21 |
| CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 (K083554) | Cliniqa Corporation | 2009-04-21 |
| ALEUTIAN IBF SYSTEM (K082698) | K2m, Inc. | 2009-04-21 |
| WELL-PASTE (K090992) | Vericom Co., Ltd. | 2009-04-21 |
| MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM (K090872) | Cardica, Inc. | 2009-04-21 |
| NIO COLOR 3MP AND MDNC-3121 (K090732) | Barco N.V. | 2009-04-20 |
| CALIX SPINAL IMPLANT SYSTEM (K083637) | X-Spine Systems, Inc. | 2009-04-20 |
| ATLAS IMPLANT SYSTEM- MINI PLUS (K090049) | Cowellmedi Co., Ltd. | 2009-04-20 |
| LANX FUSION SYSTEM (K083815) | Lanx, Inc. | 2009-04-20 |
| PARADIS VASO SHIELD (K090022) | Spinemedica, LLC | 2009-04-20 |
| MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 (K090506) | Integra LifeSciences Corporation | 2009-04-20 |
| MODIFICATION TO: S4 SPINAL SYSTEM (K090657) | Aesculap Implant Systems | 2009-04-20 |
| MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K090814) | Gyrus Acmi, Inc. | 2009-04-20 |
| LATARJET CORTICAL SCREW SET (K083096) | Tag Medical Products | 2009-04-17 |
| CAPILLARYS IMMUNOTYPING, MODEL 2100 (K082085) | Sebia | 2009-04-17 |
| ISKRA MEDICAL GREEN IRF PRESTIGE (K083590) | Iskra Medical, D.O.O. | 2009-04-17 |
| HG II FIXTURE SYSTEM (K090237) | Hiossen, Inc. | 2009-04-17 |