| K200536 — 3MTM AttestTM Rapid 5 Steam-Plus Test Pack | 3M Complany Jun 1, 2020 |
| K192601 — uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. Jun 1, 2020 |
| K193577 — SleepRight ProRx Custom Dental Guard | Splintek, Inc. Jun 1, 2020 |
| K200538 — Skeletal Dynamics Forearm Plating System | Skeletal Dynamics, Inc. Jun 1, 2020 |
| K193361 — ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. Jun 1, 2020 |
| K200897 — Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | Hartalega Sdn Bhd Jun 1, 2020 |
| K191620 — Vitls Platform | Vitls, Inc. Jun 1, 2020 |
| K193319 — XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. Jun 1, 2020 |
| K200540 — BRAINSTREAM Disposable Deep Cup EEG Electrodes | Conmed Corporation Jun 1, 2020 |
| K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation May 29, 2020 |
| K200002 — Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | 4Web, Inc. May 29, 2020 |
| K201189 — Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. May 29, 2020 |
| K201172 — CFP-3131, CFP-2222 | Mx Imaging, Inc. May 29, 2020 |
| K201178 — iLab Polaris Multi-Modality Guidance System | Boston Scientific May 29, 2020 |
| K200920 — Idys ALIF ZP 3DTi | Clariance, Sas May 29, 2020 |
| K192420 — Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. May 29, 2020 |
| K200235 — KONG-TL VBR System, KONG-C VBR System | Icotec AG May 29, 2020 |
| K200509 — ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. May 29, 2020 |
| K200511 — ROSA ONE Brain application | Medtech S.A May 29, 2020 |
| K190982 — Automatic Digital Blood Pressure Monitor | Xiamen Ants Bro Technology Co., Ltd. May 29, 2020 |
| K191334 — Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 | Matia Robotics (Us), Inc. May 29, 2020 |
| K192262 — Dental Zirconia Blocks | De Corematrix Co., Ltd. May 29, 2020 |
| K193495 — XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific May 29, 2020 |
| K200629 — Aspire Mechanical Aspirator G | Control Medical Technology May 29, 2020 |
| K200979 — DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. May 28, 2020 |
| K200116 — PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. May 28, 2020 |
| K200885 — Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation May 28, 2020 |
| K201131 — firefly T-2 | Firstkind Limited May 28, 2020 |
| K193665 — Frozen N | Yozma Bmtech Co., Ltd. May 28, 2020 |
| K192692 — Brainomix 360 e-CTA | Brainomix Limited May 28, 2020 |
| K192981 — Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | Penumbra, Inc. May 28, 2020 |
| K193539 — REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation May 28, 2020 |
| K193233 — Restoration® Modular Hip System | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) May 27, 2020 |
| K193336 — Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | Synedgen, Inc. May 27, 2020 |
| K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. May 27, 2020 |
| K192449 — Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG May 27, 2020 |
| K200525 — Medical Diode Laser Hair Removal System | Weifang Mingliang Electronics Co., Ltd. May 27, 2020 |
| K200253 — Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | Ethicon Endo-Surgery May 27, 2020 |
| K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International, Inc. May 27, 2020 |
| K200984 — Guardian Needle Electrode | Rhythmlink International, LLC May 27, 2020 |
| K192418 — Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC May 27, 2020 |
| K192652 — TRV | Interacoustics A/S May 27, 2020 |
| K192914 — Stimuplex Onvision System | Philips Medical Systems Nederland B.V. May 27, 2020 |
| K200988 — Maximus System | Hill-Rom Services Pte, Ltd. May 26, 2020 |
| K201130 — ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. May 26, 2020 |
| K193460 — The iNAP One Sleep Therapy System | Somnice, Inc. May 26, 2020 |
| K193441 — Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. May 26, 2020 |
| K200944 — UNIEXPERT 2 PLUS | Adani May 26, 2020 |
| K201111 — GentleMax Pro Plus | Candela Corporation May 26, 2020 |
| K200305 — NPseal | Guard Medical, Inc. May 26, 2020 |