| K192619 — Pitkar Locked Plating System | S.H.Pitkar Orthotools Pvt. , Ltd. Feb 27, 2020 |
| K192096 — Omnia Medical Trauma Screws | Omnia Medical, LLC Feb 27, 2020 |
| K193268 — APrioCore Plus | Apriomed AB Feb 27, 2020 |
| K200247 — Fusion Quattro Extraction Balloon | Wilson-Cook Medical, Inc. Feb 27, 2020 |
| K192192 — VSP System | 3D Systems Feb 26, 2020 |
| K191463 — DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC Feb 26, 2020 |
| K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated Feb 26, 2020 |
| K200197 — ARK Fentanyl II Assay | Ark Diagnostics, Inc. Feb 26, 2020 |
| K200189 — Luna Dental Implant System- Healing Abutment | Shinhung Mst Co., Ltd. Feb 26, 2020 |
| K191402 — Heater-Cooler System 3T | Livanova Deutschland, GmbH Feb 25, 2020 |
| K193414 — Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. Feb 25, 2020 |
| K200234 — Surgical laser fibers | Quanta System Spa Feb 25, 2020 |
| K200016 — uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. Feb 25, 2020 |
| K192253 — SonicEye Dual-Array Ultrasound System | Sonivate Medical, Inc. Feb 25, 2020 |
| K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators | Ortho Clinical Diagnostics Feb 25, 2020 |
| DEN190020 — iTind System | Medi-Tate , Ltd. Feb 25, 2020 |
| K191389 — Allcem Veneer APS | Dentscare Ltda Feb 25, 2020 |
| K200178 — Ez3D-i /E3 | Ewoosoft Co., Ltd. Feb 25, 2020 |
| K192898 — PneumoLiner | Advanced Surgical Concepts Feb 25, 2020 |
| K191858 — Pylant Monitor | Kal-Med, LLC Feb 24, 2020 |
| K192756 — Aquadex FlexFlow System 2.0 | Chf Solutions, Inc. Feb 24, 2020 |
| K193180 — Alliance Augmented Glenoid | Zimmer, Inc. Feb 24, 2020 |
| K191474 — NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | Fresenius Medical Care Renal Therapies Group, LLC Feb 24, 2020 |
| K193451 — Titanium Interference Screws | Biomet, Inc. Feb 24, 2020 |
| K192855 — DELTA XTEND(TM) Reverse Shoulder System | Depuy(Ireland) Feb 24, 2020 |
| K193412 — NEXXT MATRIXX System | Nexxt Spine, LLC Feb 24, 2020 |
| K200214 — 3D Predict | 3D Smile USA, Inc. Feb 24, 2020 |
| K193308 — T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH Feb 23, 2020 |
| K190363 — Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage | Omnia Medical, LLC Feb 21, 2020 |
| K193118 — TGS Guidewire and updated Scopis Software | Stryker Ent Feb 21, 2020 |
| K191894 — Upper Arm Blood Pressure Monitor | Shenzhen Zhengkang Technology Co., Ltd. Feb 21, 2020 |
| K191030 — Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | Life Technologies Corporation Feb 21, 2020 |
| K191728 — ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC Feb 21, 2020 |
| K192691 — PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. Feb 21, 2020 |
| DEN190023 — AmplideX Fragile X Dx & Carrier Screen Kit | Asuragen, Inc. Feb 21, 2020 |
| K192799 — Glenoid Baseplate with Screw | Fx Shoulder USA, Inc. Feb 21, 2020 |
| K192072 — Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) Feb 21, 2020 |
| K191740 — DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH Feb 21, 2020 |
| K190641 — AR_N SLA Type Implant System | Biotem Co., Ltd. Feb 21, 2020 |
| K191536 — Biatain Silicone Ag | Coloplast A/S Feb 21, 2020 |
| K192832 — Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation Feb 21, 2020 |
| K200184 — SmoothSkin Pure | Cyden Limited Feb 21, 2020 |
| K192851 — OASIS MRI System | Hitachi Healthcare Americas Feb 21, 2020 |
| K192491 — Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. Feb 21, 2020 |
| K192600 — Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa Feb 21, 2020 |
| K191646 — Beamscan MR | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Feb 21, 2020 |
| K191313 — Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development Feb 21, 2020 |
| K192263 — UCLA CCM Abutment | Dio Corporation Feb 21, 2020 |
| K200161 — 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | Jvckenwood Corporation Feb 21, 2020 |
| K191697 — Cardiac Monitor 1500 | Zynex Medical, Inc. Feb 21, 2020 |