| K182450 — Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 19, 2018 |
| K181621 — Stable-C Interbody System | Nexus Spine, LLC Oct 19, 2018 |
| K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. Oct 19, 2018 |
| K182586 — DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port | Medtronic, Inc. Oct 19, 2018 |
| K182644 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott Oct 19, 2018 |
| K181433 — MAGNETOM Vida | Siemens Medical Solutions USA, Inc. Oct 19, 2018 |
| K180213 — Titanium TomoFix Medial High Tibia Plate Anatomical | Synthes (USA) Products, LLC Oct 19, 2018 |
| K182590 — 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA | GE Healthcare Oct 19, 2018 |
| K180474 — TNI softFlow 50 | Tni Medical AG Oct 18, 2018 |
| K182239 — OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC Oct 18, 2018 |
| K181373 — Extended Lipid Panel Assay | Laboratory Corporation Of America Holdings Oct 18, 2018 |
| K180708 — Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit | Xeridiem Medical Devices, A Spectrum Plastics Group Company Oct 18, 2018 |
| K181942 — Quantum Ventilation Module | Spectrum Medical , Ltd. Oct 18, 2018 |
| K181718 — BD FlowSmart Set/MiniMed Pro-Set | Becton, Dickinson And Company Oct 18, 2018 |
| K182348 — 14HK701G-W | Lg Electronics.Inc Oct 18, 2018 |
| K182591 — RadiForce RX360, RX360-AR | Eizo Corporation Oct 18, 2018 |
| K181618 — Reprocessed Torqr Diagnostic EP Catheter | Innovative Health, LLC Oct 18, 2018 |
| K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Phamatech, Inc. Oct 18, 2018 |
| K181803 — Medax Biopsy Systems III | Medax Srl Unipersonale Oct 18, 2018 |
| K182569 — Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH Oct 18, 2018 |
| K181941 — Swift System | Emblation , Ltd. Oct 18, 2018 |
| K182550 — Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. Oct 17, 2018 |
| K180941 — Ortho System | 3Shape A/S Oct 17, 2018 |
| K180240 — Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. Oct 17, 2018 |
| K182034 — Arterys MICA | Arterys, Inc. Oct 17, 2018 |
| K172709 — ELAN 4 Electro Motor System Tools | Aesculap, Inc. Oct 17, 2018 |
| K181728 — Muscle Trainer | Shenzhen Kentro Medical Electronics Co., Ltd. Oct 17, 2018 |
| K181026 — OsteoBridge IDSF System | Merete GmbH Oct 17, 2018 |
| K182669 — Youlaser CO2 | Quanta System Spa Oct 17, 2018 |
| K180345 — Uroject12 Syringe Lever | Urogen Pharma, Ltd. Oct 17, 2018 |
| K182240 — PASS LP Spinal System | Medicrea International SA Oct 17, 2018 |
| K182551 — Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. Oct 17, 2018 |
| K182546 — Alphenix, INFX-8000H/B, V8.0 | Canon Medical Systems Corporation Oct 17, 2018 |
| K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. Oct 16, 2018 |
| K182154 — Depuy Synthes Femoral Neck System | Synthes (USA) Products, LLC Oct 16, 2018 |
| K182614 — RCT700 | Ray Co., Ltd. Oct 16, 2018 |
| K180568 — KidCap | Eastern Cranial Affiliates, LLC Oct 16, 2018 |
| K181937 — Pump In Style Advanced, Advanced Personal Double Breastpump | Medela, LLC Oct 16, 2018 |
| K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. Oct 16, 2018 |
| K182036 — NeuroBlate System | Monteris Medical, Oct 15, 2018 |
| K180418 — Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. Oct 15, 2018 |
| K182233 — FlowTriever Retrieval/Aspiration System | Inari Medical Oct 15, 2018 |
| K181815 — DynaBridge | Fusion Orthopedics, LLC Oct 15, 2018 |
| K181910 — BracePaste MTP Light Cure Primer | American Orthodontics Oct 15, 2018 |
| K181999 — Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation Oct 12, 2018 |
| K181607 — Thorecon Rigid Fixation System | A & E Medical Corporation Oct 12, 2018 |
| K181717 — Life Spine Laminoplasty System | Life Spine, Inc. Oct 12, 2018 |
| K182536 — Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap | Exactech, Inc. Oct 12, 2018 |
| K182522 — Penumbra System (Modified 110 Aspiration Tubing) | Penumbra, Inc. Oct 12, 2018 |
| K180292 — PENTAX Video Upper G.I. Scope EG34-i10 | Pentax Medical Of America, Inc. Oct 12, 2018 |