| K180782 — Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Apr 20, 2018 |
| K173900 — Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. Apr 20, 2018 |
| K180219 — JO H2O Flavored Personal Lubricants | United Consortium Apr 20, 2018 |
| K173902 — Neodent Implant System GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Apr 20, 2018 |
| K172154 — Isolette 8000 plus | Draeger Medical Sytems, Inc. Apr 19, 2018 |
| K172167 — Zenith Flex System | Inneuroco, Inc. Apr 19, 2018 |
| K180576 — Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | Lpi, Inc. Apr 19, 2018 |
| K180731 — Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) Apr 19, 2018 |
| K172427 — AViTA Radar Thermo NT16 Series IR Thermometer | Avita Corporation Apr 19, 2018 |
| K172887 — XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) | Guangzhou Xinbo Electronic Co., Ltd. Apr 19, 2018 |
| K173757 — VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. Apr 19, 2018 |
| K180873 — Medtronic Model 53401 External Pulse Generator (EPG) | Medtronic, Inc. Apr 19, 2018 |
| K180684 — CoaguChek XS Plus System | Roche Diagnostics Apr 19, 2018 |
| K172588 — Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated Apr 19, 2018 |
| K172416 — Synermed Opiate Enzyme Immunoassay | Infrared Laboratory Systems, LLC (Dba Synermed) Apr 19, 2018 |
| K180102 — Embozene Color-Advanced Microspheres | Boston Scientific Apr 19, 2018 |
| K180693 — CoaguChek XS Pro System | Roche Diagnostics Apr 19, 2018 |
| K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical, Ltd. Apr 19, 2018 |
| K172365 — Panoramic Oxygen Mask (POM) | Pom Medical, LLC Apr 19, 2018 |
| K172478 — TENS device-EmeTerm, CinvStop | Wat Medical Technology (Ningbo) Co., Ltd. Apr 19, 2018 |
| K173472 — MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments | Medacta International S.A. Apr 19, 2018 |
| K172477 — iSchemaView RAPID | Ischemaview, Inc. Apr 19, 2018 |
| K172919 — EV-804 OTC Pain Relief TENS | Everyway Medical Instruments Co.,Ltd Apr 19, 2018 |
| K172598 — Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE | Itw Contamination Control Electronics Apr 19, 2018 |
| K172306 — SuperSlyde Personal Lubricant | Icm Pharma Pte, Ltd. Apr 19, 2018 |
| K180336 — syngo.MR Applications | Siemens Medical Solutions USA, Inc. Apr 19, 2018 |
| K171720 — encevis | Ait Austrian Institute Of Technology GmbH Apr 19, 2018 |
| K172880 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH Apr 18, 2018 |
| K173661 — Wingman 35 Crossing Catheter | Reflow Medical, Inc. Apr 18, 2018 |
| K180081 — RAILWAY Sheathless Access System | Cordis Corporation Apr 18, 2018 |
| K172947 — HALF DOME Posterior Lumbar Interbody System | Astura Medical Apr 18, 2018 |
| K173615 — Stryker Universal Select Sterilization Tray System | Paragon Medical Apr 18, 2018 |
| K180851 — VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. Apr 18, 2018 |
| K173432 — ENZA-A Titanium ALIF | Camber Spine Technologies Apr 18, 2018 |
| K180836 — Genistrong | Genicon, Inc. Apr 18, 2018 |
| K173964 — OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. Apr 18, 2018 |
| K173317 — DiLumen C2; DiLumen Tool Mount | Lumendi, LLC Apr 17, 2018 |
| K180588 — FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device | Teleflex Medical Apr 17, 2018 |
| K173614 — Penumbra Coil 400, Ruby Coil System, POD System | Penumbra, Inc. Apr 17, 2018 |
| K172610 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S | Olympus Medical Systems Corp. Apr 17, 2018 |
| K172735 — WR19 System | Zeto, Inc. Apr 17, 2018 |
| K180416 — ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | Cardiovascular Systems, Inc. Apr 17, 2018 |
| K180078 — Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. Apr 17, 2018 |
| K173816 — NM/CT 850, NM/CT 860 | GE Healthcare Apr 17, 2018 |
| K180146 — KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. Apr 17, 2018 |
| K180914 — Aesculap Slim Clip Applier | Aesculap, Inc. Apr 17, 2018 |
| K180723 — PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. Apr 17, 2018 |
| K180353 — Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. Apr 17, 2018 |
| K180458 — FOCUS Pedicle Screw System | Nvision Biomedical Technologies, LLC Apr 17, 2018 |
| K172288 — Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy Apr 17, 2018 |