| K182018 — Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd. Oct 6, 2018 |
| K181860 — NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated Oct 5, 2018 |
| K182112 — Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC Oct 5, 2018 |
| K181868 — SHINY RPL System | Ids, Ltd. Oct 5, 2018 |
| K181531 — SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. Oct 5, 2018 |
| K181322 — MAGNETOM Sola | Siemens Medical Solutions USA, Inc. Oct 5, 2018 |
| K180054 — Royal Flush Plus High-Flow Catheter | Cook Incorporated Oct 5, 2018 |
| K173945 — Straumann SC Variobase Abutments | Institut Straumann AG Oct 5, 2018 |
| K180919 — GORE Tri-Lumen Catheter | W. L. Gore And Associates, Inc. Oct 5, 2018 |
| K181587 — ORTHOLOC SPS Shoulder Plating System | Tornier, Inc. Oct 5, 2018 |
| K181603 — EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System | K2M, Inc. Oct 5, 2018 |
| K181725 — Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | Avenu Medical, Inc. Oct 5, 2018 |
| DEN180026 — Bose Hearing Aid | Bose Corporation Oct 5, 2018 |
| K181642 — B-Laser Atherectomy System | Eximo Medical, Ltd. Oct 5, 2018 |
| K182533 — PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation Oct 4, 2018 |
| K182436 — POWEREASE System | Medtronic Sofamor Danek USA, Inc. Oct 4, 2018 |
| K182423 — MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. Oct 4, 2018 |
| K182189 — Encompass SRS Headframe ; Encompass MR SRS Headframe | Qfix Oct 4, 2018 |
| K180736 — WishBone Medical Plate and Screw System | Wishbone Medical, Inc. Oct 4, 2018 |
| K182337 — HYBRID Guidewire | Balt USA, LLC Oct 4, 2018 |
| K173076 — CURA 16; ScintCare CT16 | Fmi Medical Systems, Inc. Oct 4, 2018 |
| K180209 — Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. Oct 4, 2018 |
| K181949 — SYMPHONY OCT System | Medos International SARL Oct 4, 2018 |
| K181240 — Rhino-Laryngo Fiberscope Olympus ENF-GP2 | Olympus Medical Systems Corp. Oct 4, 2018 |
| K182059 — Prase MIS Spinal System | Gbs Commonwealth Co., Ltd. Oct 4, 2018 |
| K182122 — Ureteric Catheters | Coloplast Corp. Oct 4, 2018 |
| K182539 — 2MP Color LCD Monitor CL-R211 | Jvckenwood Corporation Oct 3, 2018 |
| K180972 — ARIX Clavicle System | Jeil Medical Corporation Oct 3, 2018 |
| K181903 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device | Varian Medical Systems, Inc. Oct 3, 2018 |
| K181196 — Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC Oct 3, 2018 |
| K181527 — On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System | ACON Laboratories, Inc. Oct 3, 2018 |
| K181138 — IS-III active System | Neobiotech Co., Ltd. Oct 3, 2018 |
| K182050 — Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch | Siemens Medical Solutions USA, Inc. Oct 3, 2018 |
| K181881 — Outlet Sacroiliac Joint Fusion System | Sij Surgical Oct 3, 2018 |
| K182115 — Vinyl Patient Examination Gloves | Pingan Medical Products Co., Ltd. Oct 3, 2018 |
| K181371 — uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. Oct 3, 2018 |
| K181370 — uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. Oct 3, 2018 |
| K181883 — FIREFLY® Midline Navigation Guide | Mighty Oak Medical, Inc. Oct 3, 2018 |
| K181867 — Deka Smartxide2 Trio | El.En Electronic Engineering Spa Oct 2, 2018 |
| K181885 — Voyant System | Viseon, Inc. Oct 2, 2018 |
| K171696 — NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. Oct 2, 2018 |
| K182051 — FUJIFILM Duodenoscope Model | Fujifilm Corporation Oct 2, 2018 |
| K173642 — KLOCKNER SURGICAL BOX | SOADCO, S.L. Oct 2, 2018 |
| K181081 — Infrared Ear Thermometer | Joytech Healthcare Co. , Ltd. Oct 2, 2018 |
| K181622 — StrataMR guider tool | Medtronic Neurosurgery Oct 1, 2018 |
| K181445 — AMSure Hydrophilic Intermittent Catheter | Amsino International, Inc. Oct 1, 2018 |
| K173716 — MPS2 Myocardial Protection System Console | Quest Medical, Inc. Oct 1, 2018 |
| K182376 — Harmony | Topcon Medical Systems, Inc. Sep 28, 2018 |
| K182039 — Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | Arthrex, Inc. Sep 28, 2018 |
| K180068 — ORISE Gel | Boston Scientific Sep 28, 2018 |