| K201494 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. Sep 17, 2020 |
| K201686 — GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide | ETHICON, Inc. Sep 17, 2020 |
| DEN190032 — HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO Sep 17, 2020 |
| K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG) | Euroimmun Us, Inc. Sep 17, 2020 |
| K182020 — Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. Sep 17, 2020 |
| K201849 — eNAT molecular collection and preservation medium | Copan Italia Spa Sep 17, 2020 |
| K201691 — Single-Use Surgical Mask With Ear Loop | Qiqihar Hengxin Medical Supplies, Ltd. Sep 17, 2020 |
| K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System | Nexxt Spine, LLC Sep 17, 2020 |
| DEN190039 — ToothWave | Home Skinovations , Ltd. Sep 17, 2020 |
| K202007 — LZI Oxycodone III Enzyme Immunoassay | Lin-Zhi International, Inc. Sep 17, 2020 |
| K200469 — PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. Sep 16, 2020 |
| K201298 — VX1 | Volta Medical Sep 16, 2020 |
| K202394 — EOSedge | Eos Imaging Sep 16, 2020 |
| K200430 — Precice® Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. Sep 16, 2020 |
| K202406 — Butterfly iQ Ultrasound System | Butterfly Network, Inc. Sep 16, 2020 |
| K201661 — Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL Sep 16, 2020 |
| K202286 — Tulsa-Pro System | Profound Medical, Inc. Sep 16, 2020 |
| K201774 — Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | Pt. Medisafe Technologies Sep 16, 2020 |
| K201369 — AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte, Ltd. Sep 16, 2020 |
| K202360 — Ziehm Vision RFD 3D | Ziehm Imaging GmbH Sep 16, 2020 |
| K201645 — Massage Compression Boots | Jkh USA, LLC Sep 15, 2020 |
| K201170 — Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation Sep 15, 2020 |
| K201664 — FIREBIRD SI Fusion System | Orthofix, Inc. Sep 15, 2020 |
| K201341 — AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. Sep 15, 2020 |
| K201656 — ARIX Elbow System | Jeil Medical Corporation Sep 15, 2020 |
| K201665 — Collaboration Live | Philips Ultrasound, Inc. Sep 15, 2020 |
| K192665 — Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, Inc. Sep 15, 2020 |
| K202347 — UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. Sep 15, 2020 |
| K200862 — Feelix Stethoscope | Sonavi Labs, Inc. Sep 14, 2020 |
| K200313 — VIVO | Catheter Precision, Inc. Sep 14, 2020 |
| K200343 — FusionFrame Ring Lock System | Glw Medical Innovation Sep 14, 2020 |
| K202227 — Artus cervical plate system | Ulrich GmbH & Co. KG Sep 14, 2020 |
| K201631 — VersaWrap Nerve Protector | Alafair Biosciences, Inc. Sep 14, 2020 |
| K201646 — Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation Sep 14, 2020 |
| K202318 — Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Sep 14, 2020 |
| K193657 — Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. Sep 12, 2020 |
| K201779 — HotDog Temperature Management Controller | Augustine Temperature Management Sep 11, 2020 |
| K192137 — IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH Sep 11, 2020 |
| K191639 — TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. Sep 11, 2020 |
| K202143 — Dynex Micro | Vilex, LLC Sep 11, 2020 |
| K201333 — SABER .035 PTA Dilatation Catheter | Cordis Corporation Sep 11, 2020 |
| K200530 — AMICUS Separator System | Fresenius Kabi AG Sep 11, 2020 |
| K201315 — PERFORM Humeral System Stem | Tornier, Inc. Sep 11, 2020 |
| K201570 — PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. Sep 11, 2020 |
| K202297 — Aline Ablation Intelligence | Mirada Medical, Ltd. Sep 11, 2020 |
| K193449 — Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | Guangdong Horigen Mother & Baby Products Co., Ltd. Sep 11, 2020 |
| K201506 — Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System | Meditech Spine, LLC Sep 11, 2020 |
| K202187 — FLEX Vessel Prep System | Venturemed Group, Inc. Sep 11, 2020 |
| K200854 — DePuy PINNACLE Dual Mobility Liner | Depuy Ireland UC Sep 11, 2020 |
| K200948 — Fitbit ECG App | Fitbit, Inc. Sep 11, 2020 |