| K200148 — LightForce Orthodontic System (LFO System) | Lightforce Orthodontics Feb 21, 2020 |
| K191407 — Novalung System | Fresenius Medical Care Renal Therapies Group, LLC Feb 21, 2020 |
| K190806 — Flowart | Asset Medikal Tasarim As. Feb 20, 2020 |
| K192922 — Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC Feb 20, 2020 |
| K193596 — Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical Feb 20, 2020 |
| K192617 — Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC Feb 20, 2020 |
| K193255 — Largo PEEK Interbody System | Flospine, LLC Feb 20, 2020 |
| K191719 — X-MIND Trium | De Gotzen S.R.L. Feb 20, 2020 |
| K193098 — Exactech® Equinoxe® Reverse Shoulder Glenospheres | Exactech, Inc. Feb 20, 2020 |
| K193015 — HydroPICC (PICC-142) | Access Vascular, Inc. Feb 20, 2020 |
| K192624 — ApneaTrak | Cadwell Industries, Inc. Feb 20, 2020 |
| K192545 — Potenza | Jeisys Medical Incorporated Feb 20, 2020 |
| K192918 — Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation Feb 20, 2020 |
| K193303 — Tinnitus Sound Generator Module | GN Hearing A/S Feb 20, 2020 |
| K193533 — WIN Flexible Nail System | Biomet, Inc. Feb 20, 2020 |
| K190406 — SDS2.2 dental implant | Sds Swiss Dental Solutions AG Feb 20, 2020 |
| K192000 — D R Burton OxyPAP | D R Burton Healthcare, LLC Feb 19, 2020 |
| K200228 — ClearCam System | Clearcam, LLC Feb 19, 2020 |
| K192460 — Sentinel Cerebral Protection System | Boston Scientific Corporation Feb 19, 2020 |
| K192973 — densitas densityai | Densitas, Inc. Feb 19, 2020 |
| K193012 — speX Support Catheter | Reflow Medical Feb 19, 2020 |
| K193209 — Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. Feb 19, 2020 |
| K200132 — Ashvins | Medicalcommunications GmbH Feb 18, 2020 |
| K193203 — MOJAVE Expandable Interbody System | K2M, Inc. Feb 18, 2020 |
| K192674 — Mixing and Delivery System | Bone Solutions, Inc. Feb 18, 2020 |
| K192381 — DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor | Scientific Pharmaceuticals Feb 18, 2020 |
| K190487 — InPen Dose Calculator | Companion Medical, Inc. Feb 18, 2020 |
| K192894 — Vita Flex CR System with LLI | Carestream Health, Inc. Feb 18, 2020 |
| K200179 — Collaboration Live | Philips Health Care Feb 18, 2020 |
| K191514 — CareStart Flu A&B Plus | Access Bio, Inc. Feb 18, 2020 |
| K193466 — Swan-Ganz Catheters | Edwards Lifesciences, LLC Feb 16, 2020 |
| K193554 — APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | Medartis AG Feb 16, 2020 |
| K192372 — ASCEND Image Viewer | Ascend Hit Feb 14, 2020 |
| K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems Feb 14, 2020 |
| K191364 — T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 | Fujimori Kogyo, Co., Ltd. Feb 14, 2020 |
| K193120 — Real Intelligence Cori | Blue Belt Technologies, Inc. Feb 14, 2020 |
| K193248 — Biograph Vision, Biograph mCT Family of PET/CTs | Siemens Medical Solutions USA, Inc. Feb 14, 2020 |
| K191737 — The Graft Bone Substitute | Purgo Biologics, Inc. Feb 14, 2020 |
| K191785 — Orion LifeSpan MEG | Compumedics Limited Feb 14, 2020 |
| K193502 — TGS Universal Headrest with Mounting Arm | Stryker Ent Feb 14, 2020 |
| K193245 — Dunamis PunchTac Suture Anchors | Dunamis, LLC Feb 14, 2020 |
| K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Feb 14, 2020 |
| K192277 — CardIQ Flow | GE Medical Systems SCS Feb 14, 2020 |
| K200083 — EMBA Hourglass Peripheral Embolization Device (PED) | Embolic Acceleration, LLC Feb 14, 2020 |
| K193567 — VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) | bioMerieux, Inc. Feb 14, 2020 |
| K192923 — Vitrea Software Package | Canon Medical Systems Corporation Feb 14, 2020 |
| K192120 — Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm | Venner Medical (Singapore) Pte, Ltd. Feb 14, 2020 |
| K193475 — OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH Feb 14, 2020 |
| K193644 — E-COM DR-2000 DR | Livermoretech, Inc. Feb 14, 2020 |
| K192662 — CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. Feb 14, 2020 |