| K200585 — Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Apr 22, 2020 |
| K200752 — DB-Orthopedics | Dimensional Bioceramics, LLC Apr 22, 2020 |
| K200185 — SYLFIRM X | VIOL Co., Ltd. Apr 22, 2020 |
| K192517 — Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corporation Apr 22, 2020 |
| K191882 — Masimo Centroid System | Masimo Corporation Apr 22, 2020 |
| K191997 — FAICO CMF System | Faico Medical, LLC Apr 22, 2020 |
| K200168 — Dermapose Access | Puregraft, LLC Apr 22, 2020 |
| K192034 — HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc | Pathway, LLC Apr 21, 2020 |
| K192609 — Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd. Apr 21, 2020 |
| K193351 — NinesAI | Nines, Inc. Apr 21, 2020 |
| K192082 — Droplet Pen Needle 34G | Htl-Strefa S.A Apr 21, 2020 |
| K193074 — Bevel Up Holder | Nsp Tech Pte, Ltd. Apr 21, 2020 |
| K192145 — Galileo Vertebral Body Replacement Device | Bright Spine Apr 21, 2020 |
| K192492 — EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC Apr 21, 2020 |
| K193161 — Pristine Scope | Pristine Surgical Apr 21, 2020 |
| K200053 — DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) | Dannik Apr 21, 2020 |
| K200744 — Instylla Microcatheter | Instylla, Inc. Apr 21, 2020 |
| K200745 — Lariat, Hot/Cold Snare | United States Endoscopy Group, Inc. Apr 21, 2020 |
| K200162 — Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty , Ltd. Apr 21, 2020 |
| K192701 — DIBS (Digital Indirect Bonding System) | Orthoselect, LLC Apr 21, 2020 |
| K192382 — CapKlenZ | Star Mountain Medical, Inc. Apr 20, 2020 |
| K193197 — QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. Apr 20, 2020 |
| K200559 — CarpX | Pavmed, Inc. Apr 20, 2020 |
| K193032 — KY Grosz Liquid | Rb Health (Us), LLC Apr 20, 2020 |
| K192154 — Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical Apr 20, 2020 |
| K200600 — Sentinel | C-Rad Positioning AB Apr 20, 2020 |
| K200024 — uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. Apr 20, 2020 |
| K200122 — MOTO PFJ System | Medacta International S.A. Apr 20, 2020 |
| K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | Vitalconnect, Inc. Apr 20, 2020 |
| K200121 — Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. Apr 18, 2020 |
| K191995 — S4 Screw System | Subchondral Solutions, Inc. Apr 18, 2020 |
| K200158 — LOGIQ E10 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Apr 17, 2020 |
| K200709 — Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. Apr 17, 2020 |
| K200338 — ProLift Lateral Fixated | Life Spine, Inc. Apr 17, 2020 |
| K192552 — Irradiation Cosmetic Device | Chongqing Peninsula Medical Technology Co., Ltd. Apr 17, 2020 |
| K200712 — Rumble Tuff Electric Breast Pump | A Cute Baby, Inc. Apr 17, 2020 |
| K200733 — Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation Apr 17, 2020 |
| K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation Apr 17, 2020 |
| K191720 — BRUIS Software Suite | Mechanodontics, Inc. Apr 17, 2020 |
| K200118 — Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. Apr 17, 2020 |
| K200868 — SI-Restore Sacroiliac Joint Fixation System | Biofusion Medical Apr 17, 2020 |
| K193588 — DD Contrast | Dental Direkt GmbH Apr 16, 2020 |
| K192875 — Philips Biosensor BX100 | Philips Medical Systems Apr 16, 2020 |
| K200729 — HydroCision SpineJet System | Hydrocision, Inc. Apr 16, 2020 |
| DEN190028 — MyCare Psychiatry Clozapine Assay Kit | Saladax Biomedical, Inc. Apr 16, 2020 |
| K200670 — EON Portable RO Water Purification System | Mar Cor Purification, Inc. Apr 16, 2020 |
| K193549 — SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC Apr 16, 2020 |
| K200755 — Caption Guidance | Caption Health Apr 16, 2020 |
| K193124 — Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter Apr 16, 2020 |
| K200547 — Traxcess 14 SELECT Guidewire | MicroVention, Inc. Apr 16, 2020 |