| PICC Tip Positioning Aid (K152261) | Nostix, LLC | 2015-10-21 |
| Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K152763) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-21 |
| HI-TORQUE BALANCE (K152709) | Abbott Vascular | 2015-10-21 |
| ProBP 2400 Digital Blood Pressure Device (K152770) | Microlife Intellectual Property GmbH | 2015-10-21 |
| EVS 3643 (K151942) | DRTECH Corporation | 2015-10-21 |
| NuVasive VuePoint II OCT System (K150474) | Nu Vasive, Incorporated | 2015-10-21 |
| Oregon Scientific (K151415) | Idt Technology Limited | 2015-10-21 |
| MHI-TM2000 Linear Accelerator System, VERO, Imavis (K152867) | Mitsubishi Heavy Industries, Ltd. | 2015-10-21 |
| S4 Cervical Spinal and Occiput Systems (K151938) | Aesculap Implant Systems, LLC | 2015-10-21 |
| ProTech Plus (K151646) | Protech Professional Products, Inc. | 2015-10-21 |
| EOS System (K152788) | Eos Imaging | 2015-10-21 |
| JOURNEY II XR Knee System (K152726) | Smith & Nephew, Inc. | 2015-10-21 |
| Palm TENS (K150308) | Heat IN A Click, LLC | 2015-10-20 |
| Temple Touch Pro (TTP) Non-invasive temperature monitoring system (K150160) | Medisim, Ltd. | 2015-10-20 |
| Ultraviolet Sun Tanning Lamp (K151674) | G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh | 2015-10-20 |
| Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (K151389) | Terumo Cardiovascular Systems Corporation | 2015-10-20 |
| Navio (K152574) | Blue Belt Technologies, Inc. | 2015-10-20 |
| MTS300 Multiple Tray Sterilization System (K152014) | Pmbs, LLC | 2015-10-20 |
| Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant (K150153) | Package Solutions, LLC | 2015-10-20 |
| Admira Fusion x-tra (K151956) | Voco GmbH | 2015-10-20 |
| Opticage Expandable Interbody Fusion Device (K152156) | Interventional Spine, Inc. | 2015-10-19 |
| Radifocus Optitorque Angiographic Catheter (K150232) | Ashitaka Factory of Terumo Corp. | 2015-10-19 |
| AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (K151636) | Abbott Medical Optics, Inc. | 2015-10-19 |
| Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel (K150156) | Ranfac, Corp. | 2015-10-19 |
| QBioScan (K150804) | Medeia, Inc. | 2015-10-19 |
| AquaC UNO H (K143617) | Vivonic GmbH | 2015-10-19 |
| Disposable Multistage Dilation Balloon Catheter (K151671) | Micro-Tech (Nanjing) Co., Ltd. | 2015-10-16 |
| ELTRAC 471 (K151640) | Enraf-Nonius, B.V. | 2015-10-16 |
| GR40CW (K152094) | Samsung Electronics Co., Ltd. | 2015-10-16 |
| Terumo SurGuard 3 Safety Hypodermic Needle (K152362) | Terumo (Philippines) Corporation | 2015-10-16 |
| Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (K150037) | Sensus Healthcare | 2015-10-16 |
| Bladeless Optical Obturators (K152663) | Intuitive Surgical, Inc. | 2015-10-16 |
| Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System (K151648) | Altus Partners, LLC | 2015-10-16 |
| Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit (K151565) | Cepheid | 2015-10-16 |
| PASS OCT Spinal System (K150918) | Medicrea International SA | 2015-10-16 |
| Arm-Type Fully Automatic Digital Blood Pressure Monitor (K152687) | Sejoy Electronics & Instruments Co., Ltd. | 2015-10-16 |
| MIS Spine Frame Instrument Case (K151347) | Thompson Surgical Instruments | 2015-10-16 |
| Rainbow Shade (K151844) | Genoss | 2015-10-16 |
| EV-820 OTC Pain Relief TENS (K151479) | Everyway Medical Instruments Co.,Ltd | 2015-10-16 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K152453) | Lensar, Inc. | 2015-10-15 |
| Aerobika OPEP Devive with Manometer (K150173) | Trudell Medical International | 2015-10-15 |
| HammerFiX Device (K152710) | Extremity Medical, LLC | 2015-10-15 |
| MONTAGE Settable, Resorbable Hemostatic Bone Putty (K152005) | Orthocon, Inc. | 2015-10-15 |
| Amendia Cervical Plate System (K152455) | Amendia, Inc. | 2015-10-15 |
| Visible Patient Suite (K151988) | Visible Patient, Sas | 2015-10-15 |
| AVERT Contrast Modulation System (K151300) | Osprey Medical, Inc. | 2015-10-15 |
| iSnare system-Lariat (K152035) | United States Endoscopy Group, Inc. | 2015-10-15 |
| MrOpen (K151466) | Paramed S.R.L. | 2015-10-15 |
| LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip (K150835) | Covidien | 2015-10-15 |
| Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe (K152633) | Edwards Lifesciences, LLC | 2015-10-15 |
| Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips (K150396) | Apex BioTechnology Corp. | 2015-10-14 |
| Mini Needle (K151571) | Ocujet, LLC | 2015-10-14 |
| AngioDynamics Mariner Angiographic Catheters (K151724) | AngioDynamics, Inc. | 2015-10-14 |
| OSS/Arcos IM Total Femur Rod (K152621) | Biomet, Inc. | 2015-10-14 |
| Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron (K150717) | M/s. Meril Endo Surgery Private Limited. | 2015-10-14 |
| Dunamis Interference Screw (K151220) | Dunamis, LLC | 2015-10-14 |
| Px HA PEEK IBF System (K151785) | Innovasis, Inc. | 2015-10-14 |
| Pantheris System (K152275) | Avinger, Inc. | 2015-10-14 |
| Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices (K150788) | Meditech Spine, LLC | 2015-10-14 |
| truFreeze System (K152668) | CSA Medical, Inc. | 2015-10-14 |
| PHIN-FX Cannulated Lag Screw System (K150693) | Ascent Medical, LLC | 2015-10-13 |
| HD-Camera HDC1000 (K152109) | W.O.M. World of Medicine GmbH | 2015-10-13 |
| BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks (K152516) | Becton, Dickinson and Company | 2015-10-13 |
| DripAssist (K150687) | Shift Labs | 2015-10-13 |
| Sensor Medical Single Use Tonometer Prism (K152308) | Sensor Medical Technology, LLC | 2015-10-13 |
| Boa Endoscopic Valve (K152140) | C2 Therapeutics, Inc. | 2015-10-13 |
| GelPOINT Transvaginal Access Platform (K143308) | Applied Medical Resources | 2015-10-13 |
| Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System (K140325) | Joinsoon Medical Technology Co, Ltd. | 2015-10-13 |
| XW-100 Automated Hematology Analyzer, XW QC CHECK (K143577) | Sysmex America, Inc. | 2015-10-12 |
| Vitrea CT Lung Density Analysis Software (K151919) | Vital Images, Inc. | 2015-10-10 |
| D2RS_AT Digital Dynamic Remote System (K150306) | Stephanix Radiological Solutions | 2015-10-10 |
| SOMATOM Definition Edge, SOMATOM Definition AS/AS+ (K152036) | Siemens Medical Solutions USA, Inc. | 2015-10-09 |
| SterilContainer S (K151242) | Aesculap, Inc. | 2015-10-09 |
| DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls (K150502) | Microgenics Corporation | 2015-10-09 |
| Powder Free Nitrile (Black) Examination Gloves (K151528) | Gallant Quality Sdn. Bhd. | 2015-10-09 |
| Amia Automated PD System with Sharesource (K151525) | Deka Research and Development | 2015-10-09 |
| Endoskeleton TCS Interbody Fusion Device (K151596) | Titan Spine, LLC | 2015-10-09 |
| Dyevert Contrast Modulation System (K151746) | Osprey Medical, Inc. | 2015-10-09 |
| REVE134 (K151719) | Kw Ear Lab, Inc. | 2015-10-09 |
| CLICKLINE Scissor Insert for Single Use (K151044) | Karl Storz Endoscopy America, Inc. | 2015-10-09 |
| G-Fix (K151541) | GC America, Inc. | 2015-10-09 |
| Aquilion Lightning (TSX-035A/2, V7.0) (K151833) | Toshibamedical Systems Corporation | 2015-10-09 |
| eCligner (K143499) | Eclear International Co., Ltd. | 2015-10-09 |
| Dr-Ho's Foot Pad Electrode (K151693) | Drtv Asia, Ltd. | 2015-10-09 |
| Auto Suture Locking Trocar (K152565) | Covidien | 2015-10-09 |
| Sonablate 450 (DEN150011) | Sonacare Medical, LLC | 2015-10-09 |
| Medilas H RFID Laser Fibers (K152591) | Dornier Medtech America, Inc. | 2015-10-08 |
| X-Guide Surgical Navigation System (K150222) | X-Nav Technologies, LLC | 2015-10-08 |
| Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) (K150669) | Neoss, Ltd. | 2015-10-08 |
| OsteoReady ZircoSeal Abutments (K151169) | Osteoready, LLC | 2015-10-08 |
| Podimetrics Remote Temperature Monitoring System (K150557) | Podimetrics,Inc. | 2015-10-08 |
| AttraX Putty (K151584) | Progentix Orthobiology BV | 2015-10-08 |
| PRETTAU ANTERIOR T0 (K151490) | Zirkonzahn GmbH | 2015-10-08 |
| Passeo-18 Peripheral Dilation Catheter (K151744) | Biotronik, Inc. | 2015-10-08 |
| Passeo-14 Peripheral Dilatation Catheter (K152240) | Biotronik, Inc. | 2015-10-08 |
| FilmArray Meningitis/Encephalitis(ME) Panel (DEN150013) | Biofire Diagnostics, LLC | 2015-10-08 |
| WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT (K134036) | Loktal Medical Electronics Ind. Com. Ltda- Epp | 2015-10-08 |
| CONCORDE Bullet Spinal System (K151352) | Medos International SARL | 2015-10-08 |
| Single Use Balloon Dilator V (with Knife) (K150142) | Olympus Medical Systems Corp. | 2015-10-08 |
| MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM (K152550) | Medicalgorithmics S.A. | 2015-10-08 |