| K180714 — Probe Covers for Thermometers | K-Jump Health Co., Ltd. Sep 24, 2018 |
| K180916 — iNtuition-T1 Mapping and T2/T2* Mapping | Terarecon,Inc. Sep 24, 2018 |
| K181769 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Sep 21, 2018 |
| K180338 — Cellulize | Ward Photonics, LLC Sep 21, 2018 |
| K181200 — AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. Sep 21, 2018 |
| K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | United States Endoscopy Group, Inc. Sep 21, 2018 |
| K182043 — Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | Hebei Titans Hongsen Medical Technology Co., Ltd. Sep 21, 2018 |
| K173960 — DePuy Corail AMT Hip Prosthesis | Depuy France S.A.S. Sep 21, 2018 |
| K180029 — Malecot Nephrostomy Catheter/Stent Set | Cook Incorporated Sep 21, 2018 |
| K171947 — SOLOASSIST II | Aktormed GmbH Sep 21, 2018 |
| K181926 — InVivo Web Viewer | Anatomage, Inc. Sep 21, 2018 |
| K181665 — BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN | Becton, Dickinson And Company Sep 21, 2018 |
| K181702 — Tranquil-L Interbody System | Nexus Spine, LLC Sep 21, 2018 |
| K181789 — VeriSuite | Medcom GmbH Sep 21, 2018 |
| DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers For Disease Control And Prevention Sep 21, 2018 |
| K172418 — OpenSight | Novarad Corporation Sep 21, 2018 |
| K181006 — BB-613 Watch Oximeter | Bio-Beat Technologies , Ltd. Sep 21, 2018 |
| K182345 — Spineology Navigation Instruments | Spineology, Inc. Sep 21, 2018 |
| K182310 — Volpara Imaging Software | Volpara Health Technologies Limited Sep 21, 2018 |
| K180144 — Agile Esophageal Stent System | Boston Scientific Corporation Sep 21, 2018 |
| K181034 — Pocket Colposcope System | Hadleigh Health Technologies, LLC Sep 21, 2018 |
| K181616 — PSM 3-Way Silicone Foley Catheter | Pathway, LLC Sep 21, 2018 |
| K180489 — TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant Sep 21, 2018 |
| K181305 — OralTox Oral fluid Drug Test | Premier Biotech, Inc. Sep 20, 2018 |
| K173898 — MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) Sep 20, 2018 |
| K181726 — Medline Patient Cables and Lead Wires | Medline Industries, Inc. Sep 20, 2018 |
| K181995 — Chiral Surgical Pedicle Screw System | Chiral Surgical Sep 20, 2018 |
| K180366 — EndoTool SubQ | Al Pacheco And Associates Sep 20, 2018 |
| K181420 — Aequalis Flex Revive Shoulder System | Tornier, Inc. Sep 20, 2018 |
| K182340 — NICO Myriad | Nico Corporation Sep 20, 2018 |
| K181783 — LOGIQ P9; LOGIQ P7 | GE Healthcare Sep 20, 2018 |
| K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers For Disease Control And Prevention Sep 20, 2018 |
| K181199 — Katalyst Mark 1 Muscle Stimulation System Model 2 | Katalyst, Inc. Sep 20, 2018 |
| K182080 — Scope Antifogging System | Xodus Medical, Inc. Sep 19, 2018 |
| K181449 — Ortoma Treatment Solution - OTS | Ortoma AB Sep 19, 2018 |
| K181229 — TirboLOX-C Cervical IBFD | Captiva Spine, Inc. Sep 19, 2018 |
| K180894 — Magnetic Surgical System | Levita Magnetics International Corp Sep 19, 2018 |
| K181349 — Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens | Visco Vision, Inc. Sep 19, 2018 |
| K180781 — Bard Vertus Foley Catheter | C.R. Bard, Inc. Sep 19, 2018 |
| K181328 — T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. Sep 19, 2018 |
| K182286 — Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. Sep 19, 2018 |
| K173141 — CSM Submerged3-L Implant System | Csm Implant Sep 19, 2018 |
| K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | Stimwave Technologies Incorporated Sep 19, 2018 |
| K173982 — FORTIFY Corpectomy Spacers | Globus Medical, Inc. Sep 19, 2018 |
| K181734 — Beurer IPL 8500 device/ IPL VelvetSkin Pro | Home Well Trading, Ltd. Sep 19, 2018 |
| K180893 — IHM Technology Bandage | Protege Biomedical Sep 19, 2018 |
| K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath | Access Scientific, LLC Sep 18, 2018 |
| K173830 — MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. Sep 18, 2018 |
| K181233 — Elecsys FT4 III | Roche Diagnostics Sep 18, 2018 |
| K182157 — BioSign Flu A+B | Princeton BioMeditech Corp. Sep 18, 2018 |