| K181167 — Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd. Sep 2, 2018 |
| K181466 — Cadwell Zenith System | Cadwell Industries, Inc. Sep 1, 2018 |
| K182107 — CarriGen PF | Etex Corporation Aug 31, 2018 |
| K173368 — Reusable & Disposable SpO2 Sensors | Shenzhen Coreray Technology, Ltd. Aug 31, 2018 |
| K180006 — AmCAD-UT Detection 2.2 | Amcad Biomed Corporation Aug 31, 2018 |
| K181228 — IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. Aug 31, 2018 |
| K181482 — myTAP2 | Airway Management, Inc. Aug 31, 2018 |
| K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. Aug 31, 2018 |
| K180185 — BIO-C REPAIR | Angelus Industria DE Produtos Odontologicos S/A Aug 31, 2018 |
| K171549 — Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. Aug 31, 2018 |
| K181225 — ALTAPORE | Baxter Healthcare Corporation Aug 31, 2018 |
| K180866 — CareSens S Fit Blood Glucose Monitoring System | I-Sens, Inc. Aug 31, 2018 |
| K173477 — ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Icu Medical, Inc. Aug 31, 2018 |
| K181543 — Cure OPEL-C Plate System | Meditech Spine, LLC Aug 31, 2018 |
| K180888 — LYFT | Uplevity, Inc. Aug 30, 2018 |
| K180536 — Neodent Implant System GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Aug 30, 2018 |
| K173623 — Anchor plate | Biomaterials Korea, Inc. Aug 30, 2018 |
| K173648 — Spectralis HRA + OCT and variants | Heidelberg Engineering GmbH Aug 30, 2018 |
| K173380 — b-ONE® Total Hip System | B-One Ortho, Corp. Aug 30, 2018 |
| K181262 — SpineJack Expansion Kit | Vexim SA Aug 30, 2018 |
| K181513 — Arthrex PushLock Tenodesis Anchor | Arthrex, Inc. Aug 30, 2018 |
| K181997 — Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A Aug 30, 2018 |
| K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set | Quidel Corporation Aug 30, 2018 |
| K181486 — DEKA Motus AY | El.En Electronic Engineering Spa Aug 30, 2018 |
| K173042 — Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. Aug 30, 2018 |
| K182024 — Dissecting Balloon System | Applied Medical Resources Corp. Aug 30, 2018 |
| K180073 — Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set | Shenzhen Vitavitro Bio-Tech Co., Ltd. Aug 29, 2018 |
| K180802 — Meta P&Bond | Meta Biomed Co., Ltd. Aug 29, 2018 |
| K181295 — Genesys Spine AIS-C Cervical Stand-Alone System | Genesys Spine Aug 29, 2018 |
| K182054 — Natrelle 133S Tissue Expander | Allergan Aug 29, 2018 |
| K181502 — Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. Aug 29, 2018 |
| K181740 — ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. Aug 29, 2018 |
| K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC Aug 29, 2018 |
| K181104 — Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style | Shenzhen Combei Technology Co., Ltd. Aug 29, 2018 |
| K182119 — CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. Aug 29, 2018 |
| K181185 — Change Healthcare Enterprise Viewer | Change Healthcare Canada Company Aug 29, 2018 |
| K173205 — Equinox Advantage | O-Two Medical Technologies, Inc. Aug 29, 2018 |
| K180496 — TruClear Elite Hysteroscope | Covidien Aug 29, 2018 |
| K181471 — ACCUFUSE Cervical System | Absolute Advantage Medical, LLC Aug 29, 2018 |
| K180610 — Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH Aug 29, 2018 |
| K181799 — ResCUBE Ligament Fixation System | Cousin Biotech Sas Aug 29, 2018 |
| K173952 — Universal SmartECG | Vectracor, Inc. Aug 28, 2018 |
| K181683 — BD MAX CT/GC/TV 20-Day QC Panel | Microbiologics, Inc. Aug 28, 2018 |
| K181069 — Disposable Insulin Pen Needle | Zhejiang Kindly Medical Devices Co., Ltd. Aug 28, 2018 |
| K181367 — Tenex Health TX System with the TXP MicroTip | Tenex Health, Inc. Aug 28, 2018 |
| K181483 — Tranquil Interbody System | Nexus Spine, LLC Aug 27, 2018 |
| K181313 — BenQ Diagnostic Ultrasound System | Qisda Corporation Aug 27, 2018 |
| K181408 — JO Classic Hybrid Personal Lubricant | United Consortium Aug 27, 2018 |
| K181473 — DENV Detect NS1 ELISA | InBios International, Inc. Aug 27, 2018 |
| K181582 — DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation Aug 27, 2018 |