| K182688 — SKR 3000 | Konica Minolta, Inc. Dec 18, 2018 |
| K181877 — Phoenix 2.4mm Atherectomy Plus System | Volcano Atheromed, Inc. Dec 17, 2018 |
| K182001 — Acucy Influenza A&B Test with the Acucy System | SEKISUI Diagnostics, LLC Dec 17, 2018 |
| K183198 — FlowTriever Retrieval/Aspiration System | Inari Medical Dec 17, 2018 |
| K172965 — Handheld VitalSigns Monitoring System | Visiomed Technology Co.,Ltd Dec 17, 2018 |
| K182433 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. Dec 17, 2018 |
| K181612 — Tyto Stethoscope (OTC) | Tyto Care , Ltd. Dec 17, 2018 |
| K182387 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. Dec 17, 2018 |
| K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx | Shanghai Venture Bio-Tech Co., Ltd. Dec 17, 2018 |
| K183348 — Reusable Silicone Cover CPRmeter 2 | Laerdal Medical AS Dec 17, 2018 |
| K180772 — Met One Czar Anterior Cervical Plate System | Met One Technologies Dec 17, 2018 |
| K180820 — Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation Dec 14, 2018 |
| K182601 — Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation Dec 14, 2018 |
| K182207 — TR90BH | Minxray, Inc. Dec 14, 2018 |
| K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation Dec 14, 2018 |
| K182194 — UV Active Implant System | Dio Corporation Dec 14, 2018 |
| K182556 — SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. Dec 14, 2018 |
| K182922 — MTS Omadacycline 0.002-32 µg/mL | Liofilchem S.R.L. Dec 14, 2018 |
| K182905 — UniPulse | Seaward Group Dec 14, 2018 |
| K182790 — Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. Dec 14, 2018 |
| K180797 — Xcess Guiding Catheter | Curatia Medical Co. Dec 14, 2018 |
| K182681 — AC5 Topical Gel | Arch Therapeutics, Inc. Dec 14, 2018 |
| K180768 — Arthrex SwiveLock Anchors | Arthrex, Inc. Dec 14, 2018 |
| K180762 — CAPI 3 HEMOGLOBIN(E) | Sebia Dec 14, 2018 |
| K181294 — Honda Walking Assist Device | Honda Motor Company, Ltd. Dec 14, 2018 |
| K181827 — Affixus Natural Nail System Humeral Nail | Zimmer GmbH Dec 14, 2018 |
| K182419 — Centricity Universal Viewer | GE Healthcare Dec 14, 2018 |
| K182296 — HyperFil-LV | Parkell, Inc. Dec 14, 2018 |
| K182900 — 3880 MRI Patient Monitoring System | Iradimed Corporation Dec 14, 2018 |
| K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use | Shanghai Venture Bio-Tech Co., Ltd. Dec 14, 2018 |
| K183162 — Affixus Hip Fracture Nail | Biomet, Inc. Dec 14, 2018 |
| K182668 — Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC Dec 14, 2018 |
| K182008 — Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard, Inc. Dec 14, 2018 |
| K182354 — SafeAir Telescopic Smoke Pencil | Lina Medical Aps Dec 14, 2018 |
| K173783 — SCIg60 Infusion System | Emed Technologies Corporation Dec 14, 2018 |
| K181374 — NRFit Syringe | Jiangsu Caina Medical Co.,Ltd Dec 14, 2018 |
| K181269 — iCertainty | Rfpi Dec 14, 2018 |
| K181344 — C.T.M Mobility Scooter | Chien TI Enterprise Co., Ltd. Dec 14, 2018 |
| K182805 — RCT800 | Ray Co., Ltd. Dec 14, 2018 |
| K182068 — Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. Dec 13, 2018 |
| K181131 — Accu-Chek Guide Me Blood Glucose Monitoring System | Roche Diabetes Care Dec 13, 2018 |
| K182434 — LaparoGuard | Mariner Endosurgery, Inc. Dec 13, 2018 |
| K181899 — ROCCIA® PLIF | Silony Medical GmbH Dec 13, 2018 |
| K181824 — CBT Screw Fixation System | U&I Corporation Dec 13, 2018 |
| K183145 — IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. Dec 13, 2018 |
| K182397 — Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascular Systems, Inc. Dec 13, 2018 |
| K180859 — PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. Dec 13, 2018 |
| K181463 — DuraSheath Introducer Sheath System | Contract Medical International, GmbH Dec 13, 2018 |
| K180359 — BTL-FR2000 | BTL Industries, Inc. Dec 13, 2018 |
| K182065 — EVOLUX CAD/CAM PMMA BLOCKS | Blue Dent Dental Dec 13, 2018 |