| K191906 — MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF | MiRus, LLC May 18, 2020 |
| K193553 — VarseoSmile Temp | Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG May 18, 2020 |
| K200878 — Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) May 18, 2020 |
| K200390 — V.A.C. DERMATAC Drape | Kci USA, Inc. May 18, 2020 |
| K200056 — Catalys Precision Laser System | Amo Manufacturng USA, LLC May 18, 2020 |
| K200866 — Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. May 17, 2020 |
| K200479 — AquaPulse Auxiliary Water Connector | Ga Health Company Limited May 15, 2020 |
| K200746 — IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. May 15, 2020 |
| K191745 — Medtronic Commander Flex | Medtronic Care Management Services May 15, 2020 |
| K193122 — Biocore9 Humeral Resurfacing System | Biocore9, LLC May 15, 2020 |
| K193058 — SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. May 15, 2020 |
| K193334 — Pristina Serena Bright | GE Healthcare May 15, 2020 |
| K200287 — BP-BT Kiosk | Ld Technology, LLC May 15, 2020 |
| K200747 — PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. May 15, 2020 |
| K193293 — XV Lung Ventilation Analysis Software | 4Dx Limited May 14, 2020 |
| K192048 — Single Use Endoscope Valves Set | Anrei Medical (Hangzhou) Co., Ltd. May 14, 2020 |
| K200701 — Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. May 14, 2020 |
| K200367 — Distal Humerus Plating System | Skeletal Dynamics, Inc. May 14, 2020 |
| K200700 — Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | Creagh Medical, Ltd. May 14, 2020 |
| K193096 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. May 14, 2020 |
| K192463 — PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | Winner Medical Co., Ltd. May 14, 2020 |
| K191826 — KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. May 14, 2020 |
| K200989 — Reliance Endoscope Processing System | STERIS Corporation May 14, 2020 |
| K193436 — VITA Ambria | Vita Zahnfabrik GmbH H Rauter & CO May 14, 2020 |
| K200997 — Lumipulse G CA19-9-N | Fujirebio Diagnostics,Inc. May 14, 2020 |
| K200317 — Support Catheter | Qxmedical, LLC May 14, 2020 |
| K201034 — Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. May 14, 2020 |
| K201053 — PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. May 14, 2020 |
| K191819 — Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | Winner Medical Co., Ltd. May 14, 2020 |
| K192694 — PAL Single-Use Cannulas | Microaire Surgical Instruments May 14, 2020 |
| K200169 — VFS1 Bipolar Electrosurgical Generator | FHC, Inc. May 14, 2020 |
| K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | Howmedica Osteonics Corp. May 13, 2020 |
| K200205 — Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | Stryker Sustainability Solutions May 13, 2020 |
| K193055 — Purzir Dental Zirconia | 3DBiocad May 13, 2020 |
| K190118 — Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | Guangzhou Xinbo Electronic Co., Ltd. May 13, 2020 |
| K200124 — InCore MPJ System | Nextremity Solutions, Inc. May 13, 2020 |
| K201011 — Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. May 13, 2020 |
| K200991 — EVOL Spinal Interbody System | Cutting Edge Spine, LLC May 13, 2020 |
| K192642 — 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. May 13, 2020 |
| K193457 — AUDERE Lumbar Spacer System | Met One Technologies May 12, 2020 |
| K192222 — EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. May 12, 2020 |
| K192930 — Dymaxeon Spine System | Back 2 Basics Direct, LLC May 12, 2020 |
| K201043 — Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang , Ltd. May 12, 2020 |
| K201136 — Cure Lumbar Plate System | Meditech Spine, LLC May 12, 2020 |
| K200026 — Disposable ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. May 12, 2020 |
| K192901 — HealthVCF | Zebra Medical Vision, Ltd. May 12, 2020 |
| K193043 — Critical Alert CommonPath Enterprise | Critical Alert May 11, 2020 |
| K192103 — Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. May 11, 2020 |
| K200213 — Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. May 11, 2020 |
| K193085 — PuraDERM Gel | 3-D Matrix, Inc. May 11, 2020 |