| K183189 — Ultra OTC Facial Toning System | Micro Current Technology, Inc. Apr 17, 2019 |
| K190688 — VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. Apr 17, 2019 |
| K183584 — JO H2O Jelly Original Personal Lubricant | United Consortium Apr 17, 2019 |
| K183638 — SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Apr 17, 2019 |
| K190082 — Straumann BLX Variobase Abutment | Institut Straumann AG Apr 17, 2019 |
| K190728 — Arthrex SwiveLock Anchors | Arthrex, Inc. Apr 17, 2019 |
| K183152 — Phoenix | Us Bionics, Inc. (Dba Suitx) Apr 17, 2019 |
| K183395 — Arthrex 2.5 mm Tenodesis Screw | Arthrex, Inc. Apr 17, 2019 |
| K182944 — Dr. Amplatz Micro Plug | Ka Medical, LLC Apr 17, 2019 |
| K182998 — Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd. Apr 17, 2019 |
| K183428 — Avulsion Forceps | STERIS Corporation Apr 16, 2019 |
| K190773 — Elecsys TSH | Roche Diagnostics Apr 16, 2019 |
| K182217 — Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. Apr 16, 2019 |
| K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation Apr 16, 2019 |
| K181541 — Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK | Andon Health Co, Ltd. Apr 16, 2019 |
| K182999 — General Cutting Contra Handpiece | Nakanishi, Inc. Apr 16, 2019 |
| K183302 — KY Banksy Aloe | Rb Health (Us), LLC Apr 16, 2019 |
| K182246 — MIST IC | Imagine Milling Technologies, LLC Apr 16, 2019 |
| K183332 — BRAXX Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. Apr 16, 2019 |
| K183548 — SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | Siemens Medical Solutions USA, Inc. Apr 15, 2019 |
| K190420 — NDOHD High Definition Imaging System (NDOHD) | Altaravision, Inc. Apr 15, 2019 |
| K190705 — WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream | Wholepower Biotech Co., Ltd. Apr 15, 2019 |
| K182924 — Diode Laser Treatment System | Weifang KM Electronics Co., Ltd. Apr 15, 2019 |
| K190320 — PreXion3D Explorer | Prexion Corporation Apr 15, 2019 |
| K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | Surgical Instrument Service And Savings, Inc. Apr 15, 2019 |
| K181844 — One Touch | Thai Nippon Rubber Industry Public Company, Ltd. Apr 15, 2019 |
| K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Sterilmed, Inc. Apr 15, 2019 |
| K181673 — Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. Apr 15, 2019 |
| K190072 — BriefCase | Aidoc Medical , Ltd. Apr 15, 2019 |
| K190690 — INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | Sorin Group Italia S.R.L. Apr 13, 2019 |
| K183490 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | Medtronic, Inc. Apr 12, 2019 |
| DEN180060 — Plenity | Gelesis, Inc. Apr 12, 2019 |
| K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. Apr 12, 2019 |
| K190658 — MIS Bunion Plating System | Crossroads Extremity Systems, LLC Apr 12, 2019 |
| K182396 — KardiaMobile, KardiaStation | AliveCor, Inc. Apr 12, 2019 |
| K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated Apr 12, 2019 |
| K182572 — InstaRISPACS / InstaZFP / InstaMobi v5.0 | Meddiff Technologies Pvt. , Ltd. Apr 12, 2019 |
| K190626 — SyncVision System | Volcano Corporation Apr 12, 2019 |
| K183015 — PuraSinus | 3-D Matrix, Inc. Apr 12, 2019 |
| K190079 — ArgenZ HT+ | The Argen Corporation Apr 12, 2019 |
| K180757 — D-Clip; D-Clip Applier | Peter Lazic GmbH Apr 12, 2019 |
| K190365 — Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. Apr 12, 2019 |
| K183599 — Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. Apr 12, 2019 |
| K190664 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG Apr 12, 2019 |
| K183202 — Deep Learning Image Reconstruction | Ge Medical Systems, LLC Apr 12, 2019 |
| K182640 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | Shandong Hengya Packaging Printing Co.,Ltd Apr 12, 2019 |
| K181912 — Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation Apr 12, 2019 |
| K182737 — 3T 32 Channel Head Coil | Nova Medical, Inc. Apr 12, 2019 |
| K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | Cs Medical, LLC Apr 12, 2019 |
| K190453 — VisCalor bulk | Voco GmbH Apr 11, 2019 |