| K193152 — Affinity | Hermes Medical Solutions AB Feb 14, 2020 |
| K192143 — Maximus System | Hill-Rom Services Pte, Ltd. Feb 14, 2020 |
| K192158 — DiaTemp | DiaDent Group International Feb 13, 2020 |
| K193168 — Agilon Moldable | Biogennix, LLC Feb 13, 2020 |
| K192022 — DiaTemp Flow | DiaDent Group International Feb 13, 2020 |
| K193489 — ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. Feb 13, 2020 |
| K190882 — XenoSure Biologic Patch | Lemaitre Vascular Feb 13, 2020 |
| K191829 — Microlife Non-Contact Infrared Forehead Thermometer | Microlife Intellectual Property GmbH Feb 13, 2020 |
| K183024 — Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda Feb 13, 2020 |
| K191689 — EleGARD Patient Positioning System | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio Feb 13, 2020 |
| K192233 — LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. Feb 13, 2020 |
| K190909 — ArtiSential Bipolar Fenestrated Forceps | Livsmed, Inc. Feb 13, 2020 |
| K192614 — Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | Megagen Implant Co., Ltd. Feb 13, 2020 |
| K193498 — Infinitt RT PACS | Infinitt Healthcare Co., Ltd. Feb 13, 2020 |
| K192414 — Praxiject 0.9% NaCl | Medxl, Inc. Feb 13, 2020 |
| K200079 — ClearPoint System and Accessories | Mri Interventions, Inc. Feb 13, 2020 |
| K193472 — OrthoCircle Spine Pedicle Screw System | Orthocircle Spine Feb 13, 2020 |
| K193224 — Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation Feb 13, 2020 |
| K192828 — Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems Corporation Feb 13, 2020 |
| K193232 — Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology | Covidien, LLC Feb 13, 2020 |
| K191828 — Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. Feb 13, 2020 |
| K192557 — Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. Feb 13, 2020 |
| K191966 — NewPrim System | Brm Extremities Feb 13, 2020 |
| K191235 — Leltek Ultrasound Imaging System | Leltek, Inc. Feb 12, 2020 |
| K193178 — Biograph Horizon | Siemens Medical Solution USA, Inc. Feb 12, 2020 |
| K191202 — CAPENERGY - C100, C200, C300, C400, C50 | Capenergy Medical S.L. Feb 11, 2020 |
| K192165 — Acteon Imaging Suite | De Gotzen S.R.L. Feb 11, 2020 |
| K192596 — ULab Systems Dental Aligner Kit | Ulab Systems, Inc. Feb 11, 2020 |
| K200182 — EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. Feb 11, 2020 |
| K191453 — Cervitec F | Ivoclar Vivadent, AG Feb 11, 2020 |
| K193013 — AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. Feb 11, 2020 |
| K192749 — Dermadry | Dermadry Laboratories, Inc. Feb 10, 2020 |
| K192841 — InPen System | Companion Medical, Inc. Feb 10, 2020 |
| K200130 — M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. Feb 10, 2020 |
| K191919 — Elos Accurate Hybrid Base | Elos Medtech Pinol A/S Feb 10, 2020 |
| K193587 — Sutter Swyng non-stick bipolar forceps, single-use | Sutter Medizintechnik GmbH Feb 10, 2020 |
| K193156 — Arthrex Mini Comprehensive Fixation System - 1.0mm Screws | Arthrex, Inc. Feb 10, 2020 |
| K193165 — MectaFix CL Fixation Button with Continuous Loop | Medacta International S.A. Feb 10, 2020 |
| K192377 — Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. Feb 10, 2020 |
| K190192 — K3Pro Konus New Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG Feb 10, 2020 |
| K200065 — cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. Feb 10, 2020 |
| K192203 — JO for Him H2O Gel Original Personal Lubricant | United Consortium Feb 10, 2020 |
| K192846 — Argen Clear Aligner, Argen Clear Aligner Premium | Argen Corporation Feb 10, 2020 |
| DEN190038 — Surfacer Inside-Out Access Catheter System | Bluegrass Vascular Technologies, Inc. Feb 10, 2020 |
| K182927 — Pulmonary Cytology Brush | Hobbs Medical, Inc. Feb 7, 2020 |
| DEN190040 — Caption Guidance | Bay Labs, Inc. Feb 7, 2020 |
| K191416 — Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Caldera Medical, Inc. Feb 7, 2020 |
| K192527 — Rochal Antimicrobial Wound Gel | Rochal Industries, LLC Feb 7, 2020 |
| K191975 — Elefix V Paste for EEG & EMG | Nihon Kohden Corporation Feb 7, 2020 |
| K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Feb 7, 2020 |