| K201227 — Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. Jul 17, 2020 |
| K193526 — Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd Jul 17, 2020 |
| K201488 — Rover | Micro-X , Ltd. Jul 17, 2020 |
| K200498 — SCENARIA View | Hitachi Healthcare Americas Jul 17, 2020 |
| K201364 — LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG Jul 17, 2020 |
| K200063 — AeroEclipse* ONE BAN | Trudell Medical International Jul 17, 2020 |
| K200680 — Synvitro Hyadase | Origio A/S, A Coopersurgical Company Jul 17, 2020 |
| K200905 — HealthMammo | Zebra Medical Vision, Ltd. Jul 16, 2020 |
| K200578 — Infrared Thermometer Model Number RN-50A,RN-50B | Ningbo Ranor Medical Science & Technology Co., Ltd. Jul 16, 2020 |
| K192386 — KeraStat Cream | Keranetics Jul 16, 2020 |
| K201272 — Geneva | Nucletron B.V. Jul 16, 2020 |
| K191698 — TiN Coated Humeral Head | Fx Shoulder USA, Inc. Jul 16, 2020 |
| K200655 — FibroScan® 630 | Echosens Jul 16, 2020 |
| K201676 — Barricaid Instrument Tray | Intrinsic Therapeutics, Inc. Jul 16, 2020 |
| K193456 — Arm Blood Pressure Monitor | Ningbo Ranor Medical Science & Technology Co., Ltd. Jul 16, 2020 |
| K201662 — REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. Jul 16, 2020 |
| K191449 — ZCA All-Poly Acetabular Cups | Zimmer, Inc. Jul 16, 2020 |
| K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. Jul 16, 2020 |
| K200497 — Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound And Primary Care Diagnostics Jul 16, 2020 |
| K201660 — KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. Jul 16, 2020 |
| K201149 — CoLink Plating System | In2Bones USA, LLC Jul 15, 2020 |
| K201005 — FullFocus | Paige.Ai, Inc. Jul 15, 2020 |
| K201064 — V30 System, V20 System, V10 System, V-FR Handpiece | Viora , Ltd. Jul 15, 2020 |
| K201080 — Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens | Visco Vision, Inc. Jul 15, 2020 |
| K200531 — iHealth Infrared No-Touch Forehead Thermometer | Andon Health Co, Ltd. Jul 15, 2020 |
| K200690 — LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. Jul 15, 2020 |
| K201018 — Encision AEM enTouch 2X Scissor | Encision, Inc. Jul 15, 2020 |
| K201234 — BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton, Dickinson And Company Jul 15, 2020 |
| K191146 — Humelock TiN Coated Glenosphere | Fx Shoulder USA, Inc. Jul 15, 2020 |
| K201614 — TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. Jul 15, 2020 |
| K201621 — Magicore II System | Innobiosurg Co., Ltd. Jul 15, 2020 |
| K201109 — CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. Jul 15, 2020 |
| K201618 — Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation Jul 15, 2020 |
| K201605 — EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage | Eit Emerging Implant Technologies GmbH Jul 15, 2020 |
| K193063 — EMBOTRAP III Revascularization Device | Neuravi, Ltd. Jul 14, 2020 |
| K200325 — Orbit Subretinal Delivery System | Orbit Biomedical Jul 14, 2020 |
| K193097 — Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Jul 14, 2020 |
| K193515 — Mako Total Knee Application | Mako Surgical Corp. Jul 14, 2020 |
| K201000 — Biodesign Staple Line Reinforcement | Cook Biotech Incorporated Jul 13, 2020 |
| K200218 — Digiscan FDX | Allengers Medical Systems Limited Jul 13, 2020 |
| K192561 — TRAUS SUS20 | Saeshin Precision Co., Ltd. Jul 13, 2020 |
| K201338 — Allograft MIS Delivery System | Lifenet Health Jul 13, 2020 |
| K200960 — Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industires, Inc. Jul 13, 2020 |
| K201276 — ExacTrac Dynamic | Brainlab AG Jul 13, 2020 |
| K201042 — PROBEAT-CR | Hitachi , Ltd. Jul 13, 2020 |
| K193628 — AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. Jul 12, 2020 |
| K193627 — Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. Jul 12, 2020 |
| K200480 — DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. Jul 10, 2020 |
| K201279 — ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG Jul 10, 2020 |
| K201389 — Resoundant Acoustic Driver System | Resoundant, Inc. Jul 10, 2020 |