| K201059 — S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. Jul 30, 2020 |
| K200060 — Reprocessed NRG Transseptal Needle | Innovative Health, LLC Jul 30, 2020 |
| K200280 — MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. Jul 30, 2020 |
| K192663 — Joimax Intracs System | Joimax GmbH Jul 30, 2020 |
| K200678 — PENTAX Medical Video Bronchoscope EB-J10 Series | Pentax Of America, Inc. Jul 30, 2020 |
| K193660 — OSSIOfiber Compression Screws | OSSIO , Ltd. Jul 30, 2020 |
| K201834 — HI-TORQUE PROCEED Guide Wire Family | Abbott Vascular Jul 30, 2020 |
| K201851 — EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Corentec Co., Ltd. Jul 30, 2020 |
| K193283 — AI-Rad Companion Prostate MR | Siemens Medical Solutions USA, Inc. Jul 30, 2020 |
| K193321 — MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. Jul 30, 2020 |
| K201786 — Arthrex Mini Hip PushLock | Arthrex, Inc. Jul 30, 2020 |
| K201186 — KY Grosz Jelly | Rb Health (Us), LLC Jul 30, 2020 |
| K182759 — BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. Jul 29, 2020 |
| K201040 — Bioflux Software II | Biotricity Jul 29, 2020 |
| K193647 — Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. Jul 29, 2020 |
| K200504 — BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-El Elektromedizinische Geraete GmbH Jul 29, 2020 |
| K200824 — Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | Cardinal Health200, LLC Jul 29, 2020 |
| K200518 — Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt. , Ltd. Jul 29, 2020 |
| K200959 — Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | Biomet UK, Ltd. Jul 29, 2020 |
| K201760 — Zoom 14 Guidewire | Scientia Vascular, LLC Jul 29, 2020 |
| K200413 — Symphony | Aroa Biosurgery , Ltd. Jul 29, 2020 |
| K201361 — PNEUMOCLEAR | W.O.M. World Of Medicine GmbH Jul 29, 2020 |
| K201616 — SyMRI | Syntheticmr AB Jul 28, 2020 |
| K192481 — AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. Jul 28, 2020 |
| K201792 — TRUSELECT Microcatheter | Boston Scientific Corporation Jul 28, 2020 |
| K201794 — Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. Jul 28, 2020 |
| K200801 — Quantisal Oral Fluid Collection Device | Immunalysis Corporation Jul 28, 2020 |
| K201434 — Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker Jul 28, 2020 |
| K192681 — Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) | Jiangsu Kangbao Medical Equipment Co., Ltd. Jul 28, 2020 |
| K200805 — Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. Jul 28, 2020 |
| K201132 — Arthrex Compression Screws | Arthrex, Inc. Jul 27, 2020 |
| K200785 — Stratum Reduced Size Foot Plating System | Nextremity Solutions, Inc. Jul 27, 2020 |
| K200550 — Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. Jul 27, 2020 |
| K201280 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery, LLC Jul 27, 2020 |
| K200242 — StaClear Syringe | Tribofilm Research, Inc. Jul 27, 2020 |
| K201479 — DemeMASK | Demetech Corporation Jul 24, 2020 |
| K193575 — Arthrex SutureTape | Arthrex, Inc. Jul 24, 2020 |
| K192669 — Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. Jul 24, 2020 |
| K193625 — Disposable Temperature Probe | Shenzhen Changke Connect Electronics Co., Ltd. Jul 24, 2020 |
| K200643 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 24, 2020 |
| K200496 — Aer X | 3B Medical, Inc. Jul 24, 2020 |
| K200927 — Transept Cervical Plate System | Neurostructures, Inc. Jul 24, 2020 |
| K201321 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System | DePuy Synthes Jul 24, 2020 |
| K193601 — Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. Jul 24, 2020 |
| K200849 — Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company Jul 24, 2020 |
| K201293 — Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. Jul 24, 2020 |
| K200742 — JUSHA-CP610 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Jul 24, 2020 |
| K200743 — Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And Jul 23, 2020 |
| K201796 — 1717SCV, 1717SGV | Rayence Co., Ltd. Jul 23, 2020 |
| K200090 — PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | Pentax Of America, Inc. Jul 23, 2020 |