| K172762 — Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. Mar 20, 2018 |
| K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Bd Mar 20, 2018 |
| K173437 — 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H | 3M Company Mar 19, 2018 |
| DEN170029 — PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC Mar 19, 2018 |
| K171912 — Double Flexible Tip Wire Guides | Cook Incorporated Mar 19, 2018 |
| K180579 — Ezee Retrieval | Genicon, Inc. Mar 19, 2018 |
| K180475 — CapLOX II® / TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. Mar 19, 2018 |
| K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Stryker Orthopaedics Mar 19, 2018 |
| K173740 — Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. Mar 19, 2018 |
| K172264 — OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation Mar 19, 2018 |
| K171863 — Anjon Bremer Halo System | Anjon Holdings, LLC Mar 19, 2018 |
| K172148 — Anchorage Bone Plating System | Stryker GmbH Mar 19, 2018 |
| K173930 — PYTHON Plate Trial Instruments | Treace Medical Concepts, Inc. Mar 19, 2018 |
| K173237 — Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist | Syendgen, Inc. Mar 19, 2018 |
| K173841 — AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm | Stryker Mar 18, 2018 |
| K180172 — FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG | Paragon Vision Sciences Mar 16, 2018 |
| K171851 — SOFTXIL | Bistool Mar 16, 2018 |
| K173120 — CCM Abutment System | Innobiosurg Co., Ltd. Mar 16, 2018 |
| K180195 — Frigitronics adapter | Phakos Mar 16, 2018 |
| K180426 — Empower H35 | Quanta System Spa Mar 16, 2018 |
| K180411 — MEMO 4D | Sorin Group Italia S.R.L. Mar 16, 2018 |
| K173326 — MIS CONNECT Conical Connection Abutment | Mis Implants Technologies , Ltd. Mar 16, 2018 |
| K171542 — TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | Dr. Harold Katz, LLC (Dba Therabreath Mar 16, 2018 |
| K172516 — SurgiQuest AIRSEAL iFS System | Conmed Corporation Mar 16, 2018 |
| K172928 — Portable X-ray System | Rolence Enterprise, Inc. Mar 16, 2018 |
| K173752 — SI Screw System | Zavation Medical Products, LLC Mar 16, 2018 |
| DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences, LLC Mar 16, 2018 |
| K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial | Becton, Dickinson And Company Mar 16, 2018 |
| K172366 — Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. Mar 16, 2018 |
| K173358 — ARTAS System | Restoration Robotics, Inc. Mar 16, 2018 |
| K180129 — Imbio Segmentation Editing Tool software | Imbio, LLC Mar 16, 2018 |
| K173611 — syngo Application Software | Siemens Medical Solutions USA, Inc. Mar 16, 2018 |
| K171937 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH Mar 16, 2018 |
| K172593 — XCelliStem Wound Powder | Stemsys Mar 16, 2018 |
| K173181 — ExSpiron 1Xi | Respiratory Motion, Inc. Mar 16, 2018 |
| K173840 — Xpert CT/NG | Cepheid Mar 16, 2018 |
| K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare Mar 16, 2018 |
| K180224 — ELEMENT-TL | Elemenic Co., Ltd. Mar 15, 2018 |
| K180330 — Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL | Liofilchem S.R.L. Mar 15, 2018 |
| K180227 — Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. Mar 15, 2018 |
| K173839 — Tissue of Origin Test Kit-FFPE | Cancer Genetics, 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 |
| K173180 — Mega Plus Spine System | Bk Meditech, Co., Ltd. Mar 15, 2018 |
| K180406 — Ellipse Ydun | Ellipse A/S Mar 15, 2018 |
| K180153 — X-spine Cortical Bone Screw System | X-Spine Systems, Inc. Mar 15, 2018 |
| K180198 — NuVasive® VuePoint® II OCT System | Nu Vasive, Incorporated Mar 15, 2018 |
| K171430 — Incontinence Treatment Device, Model LT2061 | Shenzhen Dongdixin Technology Co., Ltd. Mar 15, 2018 |
| K180423 — Empower H65 | Quanta System Spa Mar 15, 2018 |
| K173811 — TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | In2Bones Sas Mar 15, 2018 |
| K171808 — TDM Plate and Screw System | Tdm Co., Ltd. Mar 15, 2018 |