| K193003 — NemoCast | Software Nemotec S.L. Jun 5, 2020 |
| K200107 — epoc Blood Analysis System | Epocal, Inc. Jun 5, 2020 |
| K191461 — Exofin Fusion Skin Closure System | Chemence Medical, Inc. Jun 5, 2020 |
| K191491 — EZ-Cover | Medxpress.Pro Jun 5, 2020 |
| K200441 — UroLift Advanced Tissue Control (ATC) System | Neotract, Inc. Jun 5, 2020 |
| K192550 — 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H | 3M Company Jun 5, 2020 |
| K193150 — Latex Examination Powder Free Glove, Aloe Vera | Top Glove Sdn. Bhd. Jun 5, 2020 |
| K200952 — Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. Jun 5, 2020 |
| K201212 — Voyant Open Fusion Device | Applied Medical Resources Corp. Jun 5, 2020 |
| K200398 — AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH Jun 5, 2020 |
| K200615 — Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) Jun 5, 2020 |
| K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. Jun 5, 2020 |
| K192952 — Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health Jun 5, 2020 |
| K200227 — Journey II XR Knee Instrument | Smith & Nephew, Inc. Jun 4, 2020 |
| K201223 — LZI Tramadol Enzyme Immunoassay | Lin-Zhi International, Inc. Jun 4, 2020 |
| K201214 — t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. Jun 4, 2020 |
| K200277 — Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. Jun 4, 2020 |
| K200057 — bioli lOL Delivery System | Ast Products, Inc. Jun 4, 2020 |
| K200949 — HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL Jun 4, 2020 |
| K200883 — CarboClear® Cervical Plate System | CarboFix Orthopedics , Ltd. Jun 4, 2020 |
| K200104 — Oxylight | Raja Trading Company, Inc. Jun 4, 2020 |
| K193555 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp Jun 4, 2020 |
| K200268 — Halo Single-Loop Snare Kit | Argon Medical Devices, Inc. Jun 3, 2020 |
| K201175 — StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. Jun 3, 2020 |
| K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | Chembio Diagnostic Systems Jun 3, 2020 |
| K200907 — Thales 3D Mr Scanner | Lap GmbH Laser Applikationen Jun 3, 2020 |
| K192310 — Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. Jun 3, 2020 |
| K200459 — pREBOA-PRO Catheter | Prytime Medical Devices, Inc. Jun 3, 2020 |
| K200974 — QLAB Advanced Quantification Software | Philips Health Care Jun 3, 2020 |
| K193021 — Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation Jun 3, 2020 |
| K200514 — Cardioblate Gemini-s Surgical Ablation Device | Medtronic Jun 3, 2020 |
| K200721 — Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) Jun 3, 2020 |
| K193226 — AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. Jun 3, 2020 |
| K200929 — Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. Jun 3, 2020 |
| K200602 — Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | CC Wellness, LLC Jun 3, 2020 |
| K200322 — Altus Spine Pedicle Screw System | Altus Partners, LLC Jun 2, 2020 |
| K200911 — MIRA Adapter | Phakos Jun 2, 2020 |
| K200889 — iMac 27 & PL 4.0 | Quantum-Spectra, LLC Jun 2, 2020 |
| K193307 — HIP7 | Brainlab AG Jun 2, 2020 |
| K201202 — MI View&GO | Siemens Medical Solutions USA, Inc. Jun 2, 2020 |
| K192779 — Bunny Wax Personal Lubricant | Reoxcyn, LLC Jun 2, 2020 |
| K200684 — gastroduodenal FTRD Set | Ovesco Endoscopy AG Jun 2, 2020 |
| K200089 — F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model | Fisher & Paykel Healthcare, Ltd. Jun 2, 2020 |
| K201101 — 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | Neocoil, LLC Jun 2, 2020 |
| K200532 — StarPore | Anatomics Pty, Ltd. Jun 2, 2020 |
| K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Pro Med Instruments GmbH Jun 2, 2020 |
| K200528 — Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism | Bausch + Lomb, Incorporated Jun 2, 2020 |
| K192864 — UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. Jun 1, 2020 |
| K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien Jun 1, 2020 |
| K200134 — Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. Jun 1, 2020 |