| K180396 — miraDry System | Miramar Labs, Inc. Mar 15, 2018 |
| K180153 — X-spine Cortical Bone Screw System | X-Spine Systems, Inc. Mar 15, 2018 |
| K180448 — INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter | Sorin Group Italia S.R.L. Mar 15, 2018 |
| K180104 — Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant | Church & Dwight Co., Inc. Mar 14, 2018 |
| K172266 — Dynarex Three-Way Stopcock | Dynarex Corporation Mar 14, 2018 |
| K172431 — Cardiovascular Analzyer | Physiowave, Inc. Mar 14, 2018 |
| K173980 — Specular Microscope CEM-530 | Nidek Co., Ltd. Mar 14, 2018 |
| K173794 — AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. Mar 14, 2018 |
| K171778 — MR Wireless Gating System, Model WGS-100 | Ivy Biomedical Systems, Inc. Mar 14, 2018 |
| K172012 — star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. Mar 14, 2018 |
| K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Diasorin Molecular, LLC Mar 14, 2018 |
| K172795 — Infrared Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. Mar 14, 2018 |
| K173203 — Athena GTX Device Management Suite (ADMS) Software | Athena Gtx Mar 14, 2018 |
| K180421 — Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Mar 14, 2018 |
| K180429 — Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. Mar 14, 2018 |
| K180106 — ThinkQA | Dosisoft Mar 13, 2018 |
| K180374 — Voluson S8/ Voluson S10/ Voluson S10 Expert | GE Healthcare Mar 13, 2018 |
| K173785 — Custom Clear Aligner System | Derby Dental Laboratory Mar 13, 2018 |
| K171817 — Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated Mar 13, 2018 |
| K173459 — Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. Mar 13, 2018 |
| K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | Phadia AB Mar 13, 2018 |
| K173694 — STERIZONE VP4 Sterilizer | Tso3, Inc. Mar 13, 2018 |
| K180262 — SICAT Endo | Sicat GmbH & Co. KG Mar 12, 2018 |
| K180450 — Corvocet Biopsy System | Merit Medical Systems, Inc. Mar 12, 2018 |
| K173779 — REXMONO, PDREX | Sm Eng Co., Ltd. Mar 12, 2018 |
| K173734 — RocaJJ Soft Stents | Promepla Sam Mar 12, 2018 |
| K173583 — Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. Mar 12, 2018 |
| K173229 — Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. Mar 12, 2018 |
| K173628 — Acclarent ENT Navigation System | Acclarent, Inc. Mar 10, 2018 |
| K171764 — Fixed Core Wire Guides | Cook Incorporated Mar 9, 2018 |
| K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | Kci USA, Inc. Mar 9, 2018 |
| K180061 — UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. Mar 9, 2018 |
| K173682 — L300 Go System | Bioness, Inc. Mar 9, 2018 |
| K162616 — Wrist Type Blood Pressure Monitor | Xuzhou Yongkang Electronic Science Technology Co., Ltd. Mar 9, 2018 |
| K180159 — Klassic® Knee System | Total Joint Orthopedics, Inc. Mar 9, 2018 |
| K173078 — Powder-free Clear Vinyl Patient Examination Gloves | Yongsheng Medical Products Co., Ltd. Mar 9, 2018 |
| K171820 — Transjugular Liver Access Sets | Cook Incorporated Mar 9, 2018 |
| K173939 — Quantib Brain | Quantib B.V. Mar 9, 2018 |
| K172799 — Positional Sleep Assessment System (PoSAS) software | Advanced Brain Monitoring Mar 9, 2018 |
| K173481 — Amsco Evolution Medium Steam Sterilizer | STERIS Corporation Mar 9, 2018 |
| K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | Sofradim Production Mar 9, 2018 |
| K172057 — Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set | Cook Ireland, Ltd. Mar 9, 2018 |
| K173812 — Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. Mar 9, 2018 |
| K180057 — VORTEK URETERAL DOUBLE LOOP STENT | Coloplast Corp. Mar 9, 2018 |
| K180394 — BrightMatter Plan 1.6.0 | Synaptive Medical, Inc. Mar 9, 2018 |
| K173690 — Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Mar 9, 2018 |
| K173388 — Exactech Equinoxe Stemless Shoulder | Exactech, Inc. Mar 9, 2018 |
| K173904 — CATS Tonometer Prism | Cats Tonometer, LLC Mar 9, 2018 |
| K171150 — AW-100 | Micron Corporation Mar 8, 2018 |
| K180092 — Intellitorq | Gauthier Biomedical, Inc. Mar 8, 2018 |