| K193148 — VaPro Plus Pocket, VaPro Plus | Hollister Incorporated Dec 13, 2019 |
| K193344 — Tri-Ex Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. Dec 13, 2019 |
| K192370 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. Dec 13, 2019 |
| K192647 — neria guard Infusion Set | Unomedical A/S Dec 13, 2019 |
| K192220 — ReliOn Premier Classic Blood Glucose Monitoring System | I-Sens, Inc. Dec 13, 2019 |
| K192829 — Demetra BDEM-01 Dermatoscope | Barco N.V. Dec 13, 2019 |
| K183424 — Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda Dec 13, 2019 |
| K192362 — Aero Blue Performance Surgical Gowns | O&M Halyard, Inc. Dec 13, 2019 |
| K193194 — CrossTorq 14 Guidewire | Scientia Cardio Access, LLC Dec 13, 2019 |
| K190738 — MyShoulder Placement Guides | Medacta International S.A. Dec 13, 2019 |
| K192152 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Dec 13, 2019 |
| K193202 — EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation Dec 13, 2019 |
| K191106 — C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd Dec 13, 2019 |
| DEN190034 — Control-IQ Technology | Tandem Diabetes Care, Inc. Dec 13, 2019 |
| K190742 — EPIFLO-28 | Neogenix, LLC Dba Ogenix Dec 13, 2019 |
| K192554 — decimal3D | .Decimal, LLC Dec 13, 2019 |
| K192130 — Icobrain | Icometrix NV Dec 13, 2019 |
| K190537 — BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A Dec 12, 2019 |
| K190793 — Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. Dec 12, 2019 |
| K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set | Cook Incorporated Dec 12, 2019 |
| K193157 — Arthrex 3.9mm Corkscrew Suture Anchor | Arthrex, Inc. Dec 12, 2019 |
| K192938 — Invictus Spinal Fixation System | Alphatec Spine, Inc. Dec 12, 2019 |
| K192505 — HS50/HS60 Diagnostics Ultrasound System | Samsung Medison Co., Ltd. Dec 12, 2019 |
| K182987 — Genesys Spine 3DP Lumbar Interbody System | Genesys Spine Dec 12, 2019 |
| K190673 — Health Expert Electronic Stimulator | Shenzhen Osto Technology Company Limited Dec 12, 2019 |
| K191163 — Lumax Guiding Catheter | Cook Incorporated Dec 12, 2019 |
| DEN180056 — GSP Neonatal Creatine Kinase - MM kit | Perkinelmer, Inc. Dec 12, 2019 |
| K192340 — OptoMonitor | Opsens, Inc. Dec 12, 2019 |
| K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. Dec 11, 2019 |
| K191086 — Exciplex | Clarteis Dec 11, 2019 |
| K182739 — Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. Dec 11, 2019 |
| K192571 — NemoScan | Software Nemotec S.L. Dec 11, 2019 |
| K191618 — SleepTight Mouthpiece STZ | Michael D Williams Dds PA Dec 11, 2019 |
| K191880 — Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | Innovative Health, LLC Dec 11, 2019 |
| K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream | Hangzhou Clongene Biotech Co., Ltd. Dec 11, 2019 |
| K192149 — MIS Dental Implant System | Dentsply Sirona, Inc. Dec 11, 2019 |
| K192507 — LOSPA II Knee System | Corentec Co., Ltd. Dec 11, 2019 |
| K193126 — HI-TORQUE InfilTrac Guide Wire Family | Abbott Vascular Dec 11, 2019 |
| K190508 — EVO 450 series High Speed Handpieces | Ttbio Corp. Dec 11, 2019 |
| K193123 — FUJIFILM Distal Cap Models 33-40 | Fujifilm Corporation Dec 11, 2019 |
| K193135 — TSolution One Total Knee Application | THINK Surgical, Inc. Dec 11, 2019 |
| K192287 — Transpara | Screenpoint Medical B.V. Dec 10, 2019 |
| K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation Dec 10, 2019 |
| K192516 — Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. Dec 10, 2019 |
| K192319 — HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Dec 10, 2019 |
| K190239 — Single Use Aspiration Needle | Olympus Medical Systems Corp. Dec 10, 2019 |
| K192533 — Health Line CT CVC | Health Line International Corporation Dec 10, 2019 |
| K192442 — FFRangio | Cathworks, Ltd. Dec 9, 2019 |
| K191895 — Straumann Mini Implants | Institut Straumann AG Dec 9, 2019 |
| K192225 — Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses | Vizionfocus, Inc. Dec 9, 2019 |