| ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (K124006) | Illumina, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX PLATFORM (DEN130011) | Illumina, Inc. | 2013-11-19 |
| A.L.P.S. CALCANEAL PLATING SYSTEM (K132898) | Biomet Manufacturing Corp | 2013-11-19 |
| ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM (K132258) | Zimmer Dental, Inc. | 2013-11-19 |
| ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (K132750) | Illumina, Inc. | 2013-11-19 |
| V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS (K133276) | Kci USA, Inc. | 2013-11-19 |
| PARACE MD EKOSCOPE IS100 (K123148) | Parace, LLC | 2013-11-19 |
| UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) (K132968) | Stryker Spine | 2013-11-18 |
| FLOWER ANKLE PLATING SET (K133102) | Flower Orthopedics Corporation | 2013-11-18 |
| INTEGRA FACET FIXATION SYSTEM (K132859) | Seaspine, Inc. | 2013-11-18 |
| DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261) | Ge Medical Systems, LLC | 2013-11-18 |
| LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 (K131782) | Aap Implantate AG | 2013-11-18 |
| INTEGRITY SPINE CORE SYSTEM (K132718) | Integrity Spine | 2013-11-18 |
| V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K132741) | Kci USA, Inc. | 2013-11-15 |
| SYMPHONY RF GENERATOR (K130689) | Thermigen, Inc. | 2013-11-15 |
| VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION (K133142) | Volcano Corporation | 2013-11-15 |
| TRANSGATE GUIDE CATHETER (K132542) | Stryker Neurovascular | 2013-11-15 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (K133140) | Becton, Dickinson & CO | 2013-11-15 |
| VITEK 2 AST ST MEROPENEM (K132507) | bioMerieux, Inc. | 2013-11-15 |
| MICROCYN SCAR MANAGEMENT HYDROGEL (K131672) | Oculus Innovative Sciences | 2013-11-15 |
| MAGNETOM AERA (K132951) | Siemens Medical Solutions USA, Inc. | 2013-11-15 |
| TENSYN BAND (K131850) | Dallen Medical, Inc. | 2013-11-15 |
| DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T (K132376) | Ge Healthcare (Ge Medical Systems, LLC) | 2013-11-15 |
| ELECTRONIC PULSE STIMULATOR (K131921) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2013-11-15 |
| AUTOLITH TOUCH; URO TOUCH (K130368) | Northgate Technologies, Inc. | 2013-11-15 |
| SHARPSOLOGY 2 (K133031) | Industrial Water Solutions, Inc. | 2013-11-15 |
| ND NABIL DIB INFUSION CATHETER (K130569) | Translational Research Institute | 2013-11-15 |
| NEOVEIL (K130997) | Gunze Limited | 2013-11-15 |
| SPM-300 (K130322) | Bionet Co., Ltd. | 2013-11-15 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K133208) | Boston Scientific Corp | 2013-11-14 |
| FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT (K131778) | Maquet Cardiovascular, LLC | 2013-11-14 |
| IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS (K130829) | Iq Implants , Ltd. | 2013-11-14 |
| PEREGRINE CURVED ILLUMINATING LASER PROBE (K132614) | Peregrine Surgical , Ltd. | 2013-11-14 |
| GSP NEONATAL BIOTINIDASE KIT (K131284) | Wallac OY | 2013-11-14 |
| BOSCH BLOOD PRESSURE METER (BP5000 BT) (K131026) | Robert Bosch Healthcare Systems, Inc. | 2013-11-14 |
| DOSIMETRY CHECK VERSION 4 RELEASE 1 (K132605) | Math Resolutions, LLC | 2013-11-14 |
| MERIDIAN (K131753) | Ab Ardent | 2013-11-14 |
| ANKER DENTAL IMPLANT SYSTEM (K131165) | Alliance Global | 2013-11-14 |
| DIGITAL COLOR DOPPLER ULTASOUND SYSTEM (K132527) | Sonoscape Company Limited | 2013-11-14 |
| DIGITAL ELECTROCARDIOGRAPHS (K131262) | Sonoscape Company Limited | 2013-11-14 |
| BD Veritorâ„¢ System Flu A+B Assay (K133138) | Becton, Dickinson & CO | 2013-11-13 |
| MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA (K131904) | Ameriwater | 2013-11-13 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (K131128) | Omega Laboratories, Inc. | 2013-11-13 |
| SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS (K122252) | Medical Developments International | 2013-11-13 |
| KULAVAC (K122490) | CG Bio Co., Ltd. | 2013-11-13 |
| IDYS(TM) C (K130853) | Clariance | 2013-11-13 |
| U&U STERILE HYPODERMIC NEEDLE (K132552) | U&U Medical Technology Co, Ltd. | 2013-11-13 |
| BECE CAD ZIRKON HT+ (K132102) | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 2013-11-12 |
| I RUNE (I-200L) (K122410) | Medirune Co, Ltd. | 2013-11-12 |
| STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML (K132276) | Hospira, Inc. | 2013-11-12 |
| BIOGRAPH MMR (K133226) | Siemens Medical Solutions USA, Inc. | 2013-11-12 |
| INFINIX ANGIO WORKSTATION W/DTS SOFTWARE (K132106) | Toshiba America Medical Systems, In.C | 2013-11-12 |
| ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM (K132085) | Co-Innovation Biotech Co., Ltd. | 2013-11-12 |
| GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS (K132294) | Radiology Solutions, LLC | 2013-11-12 |
| NON-CONTACT INFRARED THERMOMETER (K131243) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2013-11-12 |
| QUADROX-IR ADULT AND SMALL ADULT (K133265) | Maquet Cardiopulmonary, AG | 2013-11-12 |
| SPECTRUM SPINE SPINOUS PROCESS DEVICE (K130066) | Spectrum Spine IP Holdings, LLC | 2013-11-12 |
| SHANGHAI PHOENIX MECHANICAL WHEELCHAIR (K130848) | Shanghai Phoenix Medical Equipment Co., Ltd. | 2013-11-12 |
| HUMELOCK II CEMENTLESS SHOULDER SYSTEM (K130759) | Fx Solutions | 2013-11-09 |
| CAYMAN MI PLATE SYSTEM (K131533) | K2m, Inc. | 2013-11-09 |
| ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM (K131767) | Orthosensor, Inc. | 2013-11-08 |
| BYTECH (K130101) | Bytech Dongtai Co., Ltd. | 2013-11-08 |
| PASS LP SPINAL SYSTEM (K132574) | Medicrea International | 2013-11-08 |
| LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (K132515) | DiaSorin, Inc. | 2013-11-08 |
| MEDIVALVE ACWIRE (K132545) | Medivalve , Ltd. | 2013-11-08 |
| K-Y BRAND LIQUIBEADS (K122061) | Johnson & Johnson Healthcare Products | 2013-11-08 |
| VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 (K132913) | GE Healthcare | 2013-11-08 |
| APNEALINK PRO (K131932) | Resmed Germany, Inc. | 2013-11-08 |
| ORTHOALIGN PLUS SYSTEM (K130387) | Orthalign, Inc. | 2013-11-08 |
| MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS (K131275) | Siemens Helathcare Diagnostics, Inc. | 2013-11-08 |
| COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT (K131240) | Cochlear Americas | 2013-11-07 |
| UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP (K131236) | Ucp Biosciences, Inc. | 2013-11-07 |
| BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (K132456) | Becton, Dickinson and Company | 2013-11-07 |
| CONCEIVE PLUS (K131355) | Sasmar, Inc. | 2013-11-07 |
| CLARISO PACS (K132799) | Clariso, Inc. | 2013-11-07 |
| AQUILION ONE VISION, V6.0 (K132222) | Toshibamedical Systems Corporation | 2013-11-07 |
| DC 7 (K131839) | Dc International, LLC | 2013-11-07 |
| G-ARM MULTISCAN SYSTEM (K131423) | Beijing East Whale Imaging Technology Co., Ltd. | 2013-11-07 |
| KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (K131841) | Kimberly-Clark Corp. | 2013-11-07 |
| Merit ASAPLP Aspiration Catheter (K132155) | Merit Medical Systems, Inc. | 2013-11-07 |
| STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) (K132006) | Hartalega Sdn Bhd | 2013-11-07 |
| BELMONT HYPERTHERMIA PUMP (K131519) | Belmont Instrument Corp. | 2013-11-06 |
| LEMAITRE 8F OCCLUSION CATHETER (K132022) | LeMaitre Vascular, Inc. | 2013-11-06 |
| PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K130419) | Genoray Co., Ltd. | 2013-11-06 |
| UNISTRIP 1 (K113135) | Unistrip Technologies, LLC | 2013-11-06 |
| RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (K130405) | Teleflex Medical | 2013-11-06 |
| ZTX ULTRASONIC DIATHERMY DEVICE (K130978) | Zetroz, Inc. | 2013-11-06 |
| SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH (K130357) | Covidien, LLC | 2013-11-06 |
| BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET (K132048) | Molnlycke Health Care Us, LLC | 2013-11-06 |
| VIDA LED SURGICAL LIGHTING SYSTEM (K132307) | Convida Healthcare & Systems Corporation | 2013-11-05 |
| NURO NEUROMODULATION SYSTEM (K132561) | Advanced Uro-Solutions, Inc. | 2013-11-05 |
| CARDIOX FLOW DETECTION SYSTEM (K122400) | Cardiox Corp. | 2013-11-05 |
| PREFERRED BLOOD GLUCOSE MONITORING SYSTEM (K122338) | Prodigy Diabetes Care, LLC | 2013-11-05 |
| LEMILLS VALVULOTOME (K132047) | LeMaitre Vascular, Inc. | 2013-11-05 |
| DICOMPACS DX-R WITH FLAT PANEL (K131211) | Oehm Und Rehbein GmbH | 2013-11-05 |
| GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T (K132241) | Depuy Mitek, A Johnson & Johnson Company | 2013-11-05 |
| ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN (K132567) | Covidien | 2013-11-05 |
| INFUSION SYRINGE SET (K131661) | Innovative Medical Manufacturing Co. | 2013-11-05 |
| EM SINUS DILATION SYSTEM (K132297) | Medtronic Xomed, Inc. | 2013-11-05 |
| LIGHTHOUSE(TM) URINARY CATHETER (K131655) | Seedings Life Science Ventures, LLC | 2013-11-04 |