| POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (K150340) | Hebei Hongsen Plastics Technology Co, Ltd. | 2015-06-18 |
| SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder (K150369) | Somnomed, Inc. | 2015-06-18 |
| Spacemaker Pro Access and Dissector System (K151356) | Covidien, LLC | 2015-06-18 |
| Fusion Black Powder-Free Nitrile Exam Glove (K150113) | Halyard Health | 2015-06-18 |
| I.V. Catheter (K142797) | Jiangxi Sanxin Medtec Co., Ltd. | 2015-06-18 |
| NanoKnife System (K150089) | AngioDynamics, Inc. | 2015-06-18 |
| DePuy Synthes T-PAL Ti Spacer (K151276) | Synthes USA Products, LLC | 2015-06-18 |
| LOGIQ e (K151028) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-06-18 |
| Nanova Flowable Composite (K150623) | Nanova Biomaterials, Inc. | 2015-06-18 |
| Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System (K142752) | Zimmer Spine, Inc. | 2015-06-18 |
| Infusomat Space Volumetric Infusion Pump (K142596) | B.Braun Medical, Inc. | 2015-06-18 |
| XIDF-AWS801, Angio Workstation, V6.10 (K150967) | Toshibamedical Systems Corporation | 2015-06-18 |
| ZIBONE ZIRCONIA BLOCKS (K140836) | Coho Technology Co., Ltd. | 2015-06-17 |
| STAR 90 (K150512) | Skanray Technologies Pvt, Ltd. | 2015-06-17 |
| truFreeze System (K150920) | CSA Medical, Inc. | 2015-06-17 |
| BELIMED STEAM STERILIZER MST-H (K141879) | Sauter AG | 2015-06-17 |
| ARDO Calypso Pro Powered Breast Pump (K150721) | Ardo Medical AG | 2015-06-17 |
| ProTrack RF Anchor Wire (K150709) | Baylis Medical Company, Inc. | 2015-06-17 |
| PALACOS R pro (K150119) | Heraeus Medical GmbH | 2015-06-17 |
| VS3-IR-MMS System (K150018) | Visionsense, Ltd. | 2015-06-17 |
| True Dilatation Balloon Valvuloplasty Catheter (K150667) | C.R. Bard, Inc. | 2015-06-17 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (K150996) | AtriCure, Inc. | 2015-06-17 |
| Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix (K141084) | Acell, Inc. | 2015-06-17 |
| dynaMX Compression Staple (K143622) | Mx Orthopedics, Corp. | 2015-06-17 |
| Vdrive system, Vdrive Duo, Vdrive with V-Sono (K150312) | Stereotaxis, Inc. | 2015-06-17 |
| NuVasive CoRoent Thoracolumbar Implants (K150994) | Nu Vasive, Incorporated | 2015-06-17 |
| ESTECEM (K150727) | Tokuyama Dental Corporation | 2015-06-17 |
| Urinary Incontinence System (K142369) | Guangzhou Finecure Medical Equipment Co.,Ltd | 2015-06-17 |
| ABL800 FLEX with AQURE connectivity (K142898) | Radiometer Medical Aps | 2015-06-17 |
| CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (K142934) | Covidien | 2015-06-17 |
| Zimmer PSI Shoulder System (K150730) | Zimmer | 2015-06-16 |
| Cavitron Touch Ultrasonic Scaling System (K150535) | Dentsply International, Inc. | 2015-06-16 |
| Navigated Disc Prep Instruments and CAPSTONE Trials (K150231) | Medtronic Sofamor Danek USA, Inc. | 2015-06-16 |
| VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR (K141919) | Ad Rem Technology Sarl | 2015-06-16 |
| OARtrac System with Skin Sensors (K150719) | Radiadyne, LLC | 2015-06-16 |
| Edwards Suture Fastening System (K150882) | Edwards Lifesciences, LLC | 2015-06-16 |
| OsteoCool V-2 RF Ablation System (K142480) | Baylis Medical Company, Inc. | 2015-06-16 |
| Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear (K150630) | Yung Sheng Optical Co., Ltd. | 2015-06-15 |
| Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (K140790) | Siemens Healthcare Diagnostics | 2015-06-15 |
| LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090) | Talladium, Inc. | 2015-06-15 |
| Chang Gung ComMed Series Dental Implant System (K142751) | Chang Gung Medical Technology Co., Ltd. | 2015-06-15 |
| Dymaxeon Spine System (K150184) | Back 2 Basics Direct, LLC | 2015-06-15 |
| Neodent Implant System (K150199) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-06-15 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| CARESCAPE R860 (K142679) | Datex-Ohmeda, Inc. | 2015-06-12 |
| JUSHA-M23C LCD Monitor (K151238) | Nanjing Jusha Display Technology Co., Ltd. | 2015-06-12 |
| Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL (K150414) | Industrial Clothings (Pvt), Ltd. | 2015-06-12 |
| DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S (K150080) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-06-12 |
| Total Knee Arthroplasty System (K150496) | Responsive Orthopedics, LLC | 2015-06-12 |
| Iliad Pedicle Screw System and Zenius Pedicle Screw System (K142835) | Medyssey USA, Inc. | 2015-06-12 |
| Opto Wire and OptoMonitor System (K142598) | Opsens, Inc. | 2015-06-12 |
| NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (K150378) | Nico Corporation | 2015-06-12 |
| Wi-3 HAL-RAR System (K150718) | Agency For Medical Innovations GmbH | 2015-06-12 |
| Luma Wrap (K142416) | Salter Labs | 2015-06-12 |
| HEARTWAY Electrically Powered Wheelchair P27 (K142783) | Heartway Medical Products Co., Ltd. | 2015-06-12 |
| NilRead (K150415) | Perceptive Software | 2015-06-12 |
| Trevo XP ProVue Retriever (4x30mm) (K150616) | Concentric Medical, Inc. | 2015-06-12 |
| MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS (K150319) | Codman & Shurtleff, Inc. | 2015-06-12 |
| BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM (K141943) | Breathe Technologies | 2015-06-12 |
| Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters (K142626) | Medela AG | 2015-06-12 |
| Vertaplex® High Viscosity (HV) Radiopaque Bone Cement (K150582) | Stryker Corporation | 2015-06-12 |
| Sonoma Cancellous Bone Screw and Washer (K150376) | Sonoma Orthopedics Products, Inc. | 2015-06-12 |
| DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K150135) | Medtronic Sofamor Danek USA, Inc. | 2015-06-11 |
| XP1000 RF (K143559) | BTL Industries, Inc. | 2015-06-11 |
| Captiva Spine SmartLOX Cervical Plate System (K141332) | Captiva Spine | 2015-06-11 |
| Pre-Formed Guidewire (K151244) | Lake Region Medical | 2015-06-11 |
| EOS PMP, EOS PMP Integrated (K150489) | Sorin Group Italia S.R.L. | 2015-06-11 |
| Synergy Cranial (K150216) | Medtronic Navigation, Inc. | 2015-06-11 |
| Personalized Physiology Analytics Engine software (K142512) | Vgbio, Inc (Dba Physiq) | 2015-06-11 |
| PulmoVia Working Channel (K150280) | Sanovas, Inc. | 2015-06-11 |
| NuVasive CoRoent Small Interbody System (K150362) | Nu Vasive, Incorporated | 2015-06-11 |
| Avenue T TLIF Cage (K142645) | Ldr Spine USA, Inc. | 2015-06-11 |
| PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (K142577) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015-06-11 |
| Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] (K150373) | Grandway Technology (Shenzhen) Limited | 2015-06-11 |
| SternSnap Angled Attachment (K150250) | Sterngold Dental, LLC | 2015-06-11 |
| Tek RMD (Tek Robotic Mobilization Device) (K150548) | Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S | 2015-06-11 |
| KM Needles (Acupuncture Needle) (K142920) | K.M.S., Inc. | 2015-06-10 |
| ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (K151260) | Cardiovascular System, Inc. | 2015-06-10 |
| LaparoVue (K150569) | Buffalo Filter, LLC | 2015-06-10 |
| Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK (K143572) | Osteomed Implantes, Ltda | 2015-06-10 |
| Affixus Tibial Nailing System (K150867) | Biomet, Inc. | 2015-06-10 |
| 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter (K151253) | Boston Scientific Limited | 2015-06-10 |
| GBR System (K143730) | Jeil Medical Corporation | 2015-06-10 |
| BD Veritor (TM) System for the Rapid Detection of Flu A+B (K151291) | Becton, Dickinson and Company | 2015-06-10 |
| Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System (K141292) | Bionime Coporation | 2015-06-09 |
| Powered Wheelchair (K142770) | Aat Alber Antriebstechnik GmbH | 2015-06-09 |
| TETRIC EVOFLOW BULK FILL (K150393) | Ivoclar Vivadent, AG | 2015-06-09 |
| extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc (K151240) | Devon Medical Products | 2015-06-09 |
| AMT Enteral Transition Adapters (K150034) | Applied Medical Technology, Inc. | 2015-06-09 |
| OASYS System (K150753) | Stryker Corporation | 2015-06-09 |
| SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) (K143520) | Crosstex | 2015-06-09 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K150593) | Hartalega Sdn Bhd | 2015-06-09 |
| Morrison Steerable Needle (K150625) | Apriomed AB | 2015-06-09 |
| Reliance Cervical IBF System (K142269) | Reliance Medical Systems, LLC | 2015-06-09 |
| Capillus 272 Office Pro (K150578) | Capillus, LLC | 2015-06-09 |
| Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (K150662) | Ypsomed AG | 2015-06-09 |
| APTUS Wrist 2.5 System (K142906) | Medartis AG | 2015-06-09 |
| ELEVATE Spinal System (K142559) | Medtronic Sofamor Danek USA, Inc. | 2015-06-09 |
| Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (K150643) | Centinel Spine, Inc. | 2015-06-08 |
| Hemogrip Patch (K143466) | Remedium Technologies, Inc. | 2015-06-08 |