| Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (K152902) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-02-18 |
| Ennova Self-adhesive Electrode (K152648) | Suzhou Ennova Electronics Technology Co.,Ltd | 2016-02-18 |
| Triumph Resin Dam (K151945) | Denali Corporation | 2016-02-18 |
| ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) (K152702) | Ent Biotech Solutions | 2016-02-18 |
| DBSWIN and VistaEasy Imaging Software (K143290) | Durr Dental AG | 2016-02-18 |
| OS2-C Compression Staple (K153395) | In2bones Sas | 2016-02-18 |
| Alpine Cemented Hip System (K153216) | Ortho Development Corporation | 2016-02-18 |
| Optimus ALIF System (K160291) | Amendia, Inc. | 2016-02-18 |
| Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (K151165) | Aesculap, Inc. | 2016-02-17 |
| CliniscanSM MRI (K153593) | Picofemto, LLC | 2016-02-17 |
| ROP Resorbable Hemostasis Material (K153095) | Resorbable Orthopedic Products, LLC | 2016-02-17 |
| ST AIA-PACK hsE2 Calibrator Set (K160113) | Tosoh Bioscience, Inc. | 2016-02-17 |
| VitalStim(R) Plus Electrotherapy System (K153224) | Djo, LLC | 2016-02-17 |
| FREND™ Free T4 Test System (K152422) | Nanoentek USA, Inc. | 2016-02-17 |
| Caspian OCT/MESA Mini/DENALI Mini Spinal System (K153370) | K2m, Incorporated | 2016-02-16 |
| NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (K153479) | Ninepoint Medical, Inc. | 2016-02-16 |
| D.N.E. External Fixation System (K151580) | Dne, LLC | 2016-02-16 |
| Radiance V3 (K153368) | Gmv Soluciones Globales Internet S.A.U. | 2016-02-16 |
| TSolution One w/ACG+ Surgical System (K153647) | THINK Surgical, Inc. | 2016-02-16 |
| FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm (K152485) | Ostial Corporation | 2016-02-16 |
| AnapnoGuard 100 Respiratory Guard System (K150157) | Hospitech Respiration , Ltd. | 2016-02-16 |
| Zimmer Virage OCT Spinal Fixation System (K153631) | Zimmer Spine, Inc. | 2016-02-16 |
| Direct Bilirubin (K152343) | Randox Laboratories Limited | 2016-02-16 |
| FUSION Vascular Graft (K153523) | Maquet Cardiovascular, LLC | 2016-02-16 |
| Clear Bi-Light (K153081) | Michael Todd, LP | 2016-02-15 |
| Intact® Gen2 System (K152596) | Intact Medical Corporation | 2016-02-15 |
| Star 60 (K151512) | Skanray Technologies Private Limited | 2016-02-14 |
| ProTrach Dualcare (K151404) | Atos Medical AB | 2016-02-12 |
| Tranberg CLS Laser Fiber (K151569) | Clinical Laserthermia Systems, AB | 2016-02-12 |
| QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (K151429) | Inova Diagnostics, Inc. | 2016-02-12 |
| Digital Electrocardiograph (K160092) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2016-02-12 |
| TraumaCad Mobile Release 2.0 (K160001) | Voyant Health, Ltd. | 2016-02-12 |
| HS SutureTape (K153307) | Riverpoint Medical | 2016-02-12 |
| Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (K152231) | Boston Scientific Corporation | 2016-02-12 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077) | Microlife Intellectual Property GmbH | 2016-02-12 |
| Adena-Zina System (K152781) | Shanghai Sanyou Medical Co, Ltd. | 2016-02-12 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K151680) | Suqian Xingye Glove Co,Ltd | 2016-02-12 |
| Masimo Root Vital Signs Monitoring System and Accessories (K151644) | Masimo Corporation | 2016-02-12 |
| Spirit Hair Removal laser Family (K153718) | Active Optical Systems , Ltd. | 2016-02-12 |
| Arthrex Synergy UHD4 System (K153218) | Arthrex, Inc. | 2016-02-12 |
| Single Use Injector NM600/610 (K153625) | Olympus Medical Systems Corp. | 2016-02-12 |
| MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws (K152187) | Merete Medical GmbH | 2016-02-12 |
| Vitoss BiModal Bone Graft Substitute Foam Strip (K153608) | Orthovita, Inc. | 2016-02-12 |
| Relieva Scout Multi-Sinus Dilation System (K153341) | Acclarent, Inc. | 2016-02-12 |
| Clear Guide SCENERGY (K153004) | Clear Guide Medical | 2016-02-12 |
| PTFE Super Sheath Introducer 2.1 (K153246) | Medcomp (Medical Components, Inc.) | 2016-02-12 |
| Pain Therapy System, Model PTS-II (K150277) | Counter Scientific Development (Gz), Ltd. | 2016-02-12 |
| BD Vacutainer UltraTouch Push Button Blood Collection Set (K153309) | Becton, Dickinson and Company | 2016-02-12 |
| WHILL Model M (K153543) | Whill, Inc. | 2016-02-12 |
| X-Suit NIR Biliary Metallic Stent (K150487) | Medinol, Ltd. | 2016-02-12 |
| CARESTREAM Vue PACS (K153103) | Carestream Health, Inc. | 2016-02-12 |
| Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist (K151918) | Bausch & Lomb, Incorporated | 2016-02-11 |
| ivWatch Model 400 (K153605) | Ivwatch, LLC | 2016-02-11 |
| Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator (K151529) | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 |
| Dental Implant System (K152555) | Ariabio International, Inc. | 2016-02-11 |
| C-VBR (K152568) | Cardinal Spine, LLC | 2016-02-11 |
| ARCHITECT SHBG (K152185) | Biokit, S.A. | 2016-02-11 |
| OptoWire Deux (K152991) | Opsens | 2016-02-11 |
| RTVue XR OCT Avanti with AngioVue Software (K153080) | Optovue, Inc. | 2016-02-11 |
| Safe Block Pen Needle (K151311) | Artsana S.P.A | 2016-02-10 |
| Cios Select (K153232) | Siemens Medical Solutions USA, Inc. | 2016-02-10 |
| CD HORIZON Spinal System (K153589) | Medtronic Sofamor Danek USA, Inc. | 2016-02-10 |
| Nutra Face Lift Model PE8050 (K150826) | Nutra Luxe MD, LLC | 2016-02-10 |
| TIO-H DIGITAL RADIOGRAPHY SENSOR (K153144) | Denttio, Inc. | 2016-02-10 |
| Anterior Cervical Plate System (K151553) | Osteomed Implantes, Ltda | 2016-02-10 |
| CapsoCam (SV-1) (K151635) | CapsoVision, Inc. | 2016-02-09 |
| Dictum Health (K152645) | Dictum Health, Inc. | 2016-02-09 |
| ENDOFLOW II - Irrigation, Warming and Suction System (K152278) | Promepla Sam | 2016-02-09 |
| Nutrisafe 2- ENFit Adaptor (K151237) | Vygon | 2016-02-09 |
| OBS Anchorage Screw (K152297) | Bomei Co, Ltd. | 2016-02-09 |
| Exofin High Viscosity Tissue Adhesive (K152476) | Chemence Medical Products, Inc. | 2016-02-09 |
| Epic Extremity Plate System (K153340) | Epic Extremity, LLC | 2016-02-09 |
| Electronic Thermometer (K152739) | Guangdong Biolight Meditech Co., Ltd. | 2016-02-09 |
| Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (K151308) | Schoelly Fiberoptic GmbH | 2016-02-09 |
| BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (K153066) | Boston Foundation For Sight | 2016-02-09 |
| DIODE LASER THERAPY SYSTEMS (K152898) | Beijing Sincoheren Science and Tech. Development Co., Ltd. | 2016-02-09 |
| Powder Free Nitrile Patient Examination Gloves, Black color (K152271) | Suqian Xingye Glove Co,Ltd | 2016-02-09 |
| Actreen Mini Intermittent Urinary Catheters (K151772) | B.Braun Medical, Inc. | 2016-02-09 |
| ExpressBraid Graft Manipulation (K152868) | Biomet Manufacturing Corp | 2016-02-08 |
| FilmArray Respiratory Panel (RP) for use with FilmArray Torch (K160068) | Biofire Diagnostics, LLC | 2016-02-08 |
| M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) (K152743) | Microline Surgical, Inc. | 2016-02-08 |
| EndoChoice Select Injection Needle (K151475) | Endochoice, Inc. | 2016-02-08 |
| Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (K153028) | Zibo Huiying Medical Products, Co. , Ltd. | 2016-02-05 |
| Stryker CMF MEDPOR Customized Implant (K153508) | Stryker | 2016-02-05 |
| PC ECG (K152427) | Edan Instruments, Inc. | 2016-02-05 |
| Cryocare CS Surgical System (K153489) | Healthtronics | 2016-02-05 |
| Vital Signs Patch System (K151835) | Lifewatch Technologies , Ltd. | 2016-02-05 |
| MOR Implant System (K153173) | Sterngold Dental, LLC | 2016-02-05 |
| AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) (K151185) | Abl Medical, LLC | 2016-02-05 |
| Love Liquid Personal Lubricant (K152168) | The Kama Sutra Company | 2016-02-05 |
| SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (K151069) | Spectra Medical Devices, Inc. | 2016-02-05 |
| YuGo System (K151955) | Biogaming , Ltd. | 2016-02-05 |
| MINIARS SCREWS (K143596) | Overmed Srl. | 2016-02-05 |
| Bridge Occlusion Balloon (K153530) | Spectranetics, Inc. | 2016-02-05 |
| N5-1 (K153054) | Nuga Medical Co., Ltd. | 2016-02-05 |
| Amecath Peripheral inserted Central Venous Catheter Sets (K152819) | Ameco Medical Industries | 2016-02-05 |
| Medline Anti-Fog Solution (K152948) | Medline Industries, Inc. | 2016-02-04 |
| DyeVert Contrast Modulation System (K153141) | Osprey Medical, Inc. | 2016-02-04 |
| NaturaLase CO2 Laser System (K152529) | Focus Medical, LLC | 2016-02-04 |
| Dr's Finder (K151274) | Good Doctors Co., Ltd. | 2016-02-04 |