| K193609 — Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. Mar 20, 2020 |
| K191838 — Clearform Aligners | Motor City Lab Works Mar 20, 2020 |
| K191657 — Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. Mar 20, 2020 |
| K193659 — iTero Element 5D | Align Technology, Inc. Mar 20, 2020 |
| K193059 — G1 40 Radiopaque Bone Cement | G21, S.R.L. Mar 19, 2020 |
| K191658 — IV Sets not made with PVC | B.Braun Medical, Inc. Mar 19, 2020 |
| K193061 — G3 40 Radiopaque Bone Cement | G21, S.R.L. Mar 19, 2020 |
| K193491 — restor3d Metallic Interference Screw | Restor3D Mar 19, 2020 |
| K200379 — Super Sheath | Togo Medikit Co., Ltd. Mar 19, 2020 |
| K191818 — F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. Mar 19, 2020 |
| K192905 — Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. Mar 19, 2020 |
| K191057 — Park's Pectus System | Tdm Co., Ltd. Mar 19, 2020 |
| K193530 — Deklene MAXX | Teleflex Medical Mar 19, 2020 |
| K191856 — Compression Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. Mar 19, 2020 |
| K200406 — Evolve Breast Pump | Hygeia II Medical Group, Inc. Mar 18, 2020 |
| K191876 — PulmoScan | Cognita Labs, LLC Mar 18, 2020 |
| K193658 — Viz ICH | Viz. Ai, Inc. Mar 18, 2020 |
| K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) | Beckman Coulter, Inc. Mar 18, 2020 |
| K200094 — speX LP Support Catheter | Reflow Medical Mar 18, 2020 |
| K200198 — WIRION | Cardiovascular Systems, Inc. Mar 18, 2020 |
| K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC Mar 18, 2020 |
| K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB Mar 18, 2020 |
| K200113 — LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG Mar 18, 2020 |
| K200418 — VIVIX-S VW | Vieworks Co., Ltd. Mar 18, 2020 |
| K193558 — HEALICOIL Knotless Suture Anchors | Smith & Nephew, Inc. Mar 18, 2020 |
| K193517 — ViziShot 2 FLEX | Olympus Surgical Technologies America Mar 18, 2020 |
| K200443 — EndoTool IV 1.10 | Monarch Medical Technologies, LLC Mar 17, 2020 |
| K192272 — Wolf445nm | A.R.C Laser GmbH Mar 17, 2020 |
| K192007 — TheraBase, TheraBase Ca | Bisco, Inc. Mar 17, 2020 |
| K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) Mar 17, 2020 |
| K200243 — ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Johnson & Johnson Vision Care, Inc. Mar 17, 2020 |
| K200433 — iBalance UKA Tibial Tray Implant | Arthrex, Inc. Mar 17, 2020 |
| K200151 — Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill | Zimmer, Inc. Mar 17, 2020 |
| K193582 — SterilContainer S2 System | Aesculap, Inc. Mar 17, 2020 |
| K192753 — NeuralScan System | Medeia, Inc. Mar 17, 2020 |
| K200136 — Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. Mar 17, 2020 |
| K191753 — Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) | Medline Industries, Inc. Mar 17, 2020 |
| K200522 — AERO CHROME* Breathable Performance Surgical Gowns | O&M Halyard, Inc. Mar 16, 2020 |
| K200110 — SANDRO Dual | Wontech Co., Ltd. Mar 16, 2020 |
| K190767 — AnatomicAligner | The Methodist Hospital Research Institute D/B/A Houston Mar 16, 2020 |
| K200097 — Response BandLoc Spinal Fixation | OrthoPediatrics Corp. Mar 16, 2020 |
| K193486 — Epic 980 | Biolase, Inc. Mar 16, 2020 |
| K191705 — OptikView GUP2103CMI | The Linden Group Corp Mar 16, 2020 |
| K193267 — Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. Mar 16, 2020 |
| K192713 — Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS Mar 16, 2020 |
| K191827 — Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. Mar 16, 2020 |
| K190495 — Transferrin | Biosystems S.A. Mar 16, 2020 |
| K200385 — CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. Mar 16, 2020 |
| K190783 — Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited Mar 14, 2020 |
| K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC Mar 13, 2020 |