| K200259 — Headless Compression Screw System | Osteocentric Extremities, LLC May 4, 2020 |
| K183110 — LIVIA | Lifecare , Ltd. May 4, 2020 |
| K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. May 4, 2020 |
| K200035 — Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. May 4, 2020 |
| K200871 — Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator | Control Medical Technology May 4, 2020 |
| K200417 — RIST Radial Access Catheter | Rist Neurovascular, Inc. May 2, 2020 |
| K200910 — BOSS Balloon Guide Catheter | Marblehead Medical May 2, 2020 |
| K200917 — Azurion R2.1 | Philips Medical Systems Nederland B.V. May 1, 2020 |
| K201012 — EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. May 1, 2020 |
| DEN190026 — iTEAR Neurostimulator | Olympic Ophthalmics, Inc. May 1, 2020 |
| K192656 — Optimized Positioning System (OPS) Insight | Corin USA May 1, 2020 |
| K192405 — Image Guidance System for Radiotherapy | Jiangsu Rayer Medical Technology Co., Ltd. May 1, 2020 |
| DEN180065 — OGmend Implant System | Woven Orthopedic Technologies, LLC May 1, 2020 |
| K200173 — Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. May 1, 2020 |
| K200571 — PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | Spineart May 1, 2020 |
| K200279 — ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | Phadia AB May 1, 2020 |
| K192286 — FUJIFILM EP-6000 Video Processor | Fujifilm Corporation May 1, 2020 |
| K200606 — O-Genesis Graft Delivery System | Orthofix, Inc. May 1, 2020 |
| K200453 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC | Yty Industry (Manjung) Sdn Bhd May 1, 2020 |
| K192295 — PDT-FACE | Beijing Adss Development Co., Ltd. May 1, 2020 |
| K200870 — Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. May 1, 2020 |
| K192633 — GUS831 Compressor Nebulizer | Globalcare Medical Technology Co., Ltd. May 1, 2020 |
| K192540 — Kitazato ET Catheters | Kitazato Corporation May 1, 2020 |
| K201004 — Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W | Iray Technology Taicang , Ltd. May 1, 2020 |
| K193523 — ArthrexVIP Web Portal | Arthrex, Inc. Apr 30, 2020 |
| K200240 — Turbett Instrument Pod | Turbett Surgical, Inc. Apr 30, 2020 |
| K200519 — CarboClear® II Pedicle Screw System | CarboFix Orthopedics , Ltd. Apr 30, 2020 |
| K192350 — Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. Apr 30, 2020 |
| K192290 — 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. Apr 30, 2020 |
| K200902 — ClickClean | Medeon Biodesign, Inc. Apr 30, 2020 |
| K200816 — SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. Apr 30, 2020 |
| K192169 — PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE Apr 30, 2020 |
| K200523 — Biolign® Roto-Loc Cervical Plate System | Elite Surgical Supplies (Pty), Ltd. Apr 30, 2020 |
| K192246 — Biowy PICC Catheter S Kit | Biowy Corporation Apr 30, 2020 |
| K191816 — M-Vizion Femoral Revision System Extension | Medacta International S.A. Apr 29, 2020 |
| K192803 — da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical Apr 29, 2020 |
| K191866 — GelPOINT Mini Advanced Access Platform | Applied Medical Apr 29, 2020 |
| K193394 — Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. Apr 29, 2020 |
| K200807 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. Apr 29, 2020 |
| DEN180055 — CARPEDIEM System | Bellco Srl (Now Part Of Medtronic, Inc) Apr 29, 2020 |
| K200327 — Evry | Synaptive Medical, Inc. Apr 29, 2020 |
| K192097 — Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. Apr 29, 2020 |
| K191992 — PELNAC Bilayer Wound Matrix | Gunze Limited Apr 29, 2020 |
| K193213 — Vicks VNT200 No Touch Forehead Thermometer | Kaz USA, Inc., A Helen Of Troy Company Apr 28, 2020 |
| K200590 — VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) | bioMerieux, Inc. Apr 28, 2020 |
| K192197 — Magicore II System | Innobiosurg Co., Ltd. Apr 28, 2020 |
| K200814 — Affixus(R) Natural Nail(R) System Humeral Nail | Zimmer GmbH Apr 28, 2020 |
| K200541 — Hive Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC Apr 28, 2020 |
| K200896 — Solstice CCI | Life Spine, Inc. Apr 28, 2020 |
| K200867 — Implantswiss Dental Implant System and Implantswiss Dental Abutment System | Novodent SA Apr 28, 2020 |