| K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Zeus Scientific, Inc. Jul 29, 2019 |
| K191797 — BiomarC Fiducial Marker | Carbon Medical Technologies Jul 29, 2019 |
| K191154 — Hair Boom 69 | Wontech Jul 29, 2019 |
| K183048 — Quantisal II Oral Fluid Collection Device | Immunalysis Corporation Jul 29, 2019 |
| K190809 — Sample Imaging for Senographe Pristina | GE Healthcare Jul 29, 2019 |
| K190569 — Shaders ZR | Digital Age Dental Lab Jul 29, 2019 |
| K191289 — Bone Screw Line Addition | Vilex IN Tennessee, Inc. Jul 29, 2019 |
| K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Zeus Scientific, Inc. Jul 29, 2019 |
| K190996 — Bonus Therapeutics Mixing and Delivery System | Bonus Therapeutics , Ltd. Jul 28, 2019 |
| K182889 — KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. Jul 26, 2019 |
| K183271 — AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. Jul 26, 2019 |
| K183280 — PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs | Smart Glove Corporation Sdn. Bhd. Jul 26, 2019 |
| K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | Ge Medical Systems, LLC Jul 26, 2019 |
| K183129 — Medtronic Total Hip Arthroplasty System | Medtronic Advanced Energy Jul 26, 2019 |
| K183486 — RapidVit Oocyte, RapidWarm Oocyte | Vitrolife Sweden AB Jul 26, 2019 |
| K190533 — Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented | Sleepnet Corporation Jul 26, 2019 |
| K191328 — Megadyne Foot Switch | Megadyne Medical Products, Inc. Jul 26, 2019 |
| K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS Jul 26, 2019 |
| K183194 — Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. Jul 26, 2019 |
| K191714 — ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. Jul 26, 2019 |
| K190685 — Hair Growth System | Xuzhou Kernel Medical Equipment Co., Ltd. Jul 26, 2019 |
| K191817 — ActivOrtho Continuous Compression Screw System | Activortho, Inc. Jul 26, 2019 |
| K190873 — Infrared Ear/Forehead Thermometer | Joytech Healthcare Co. , Ltd. Jul 26, 2019 |
| K191736 — da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | Intuitive Surgical Jul 26, 2019 |
| K191733 — The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. Jul 26, 2019 |
| K190949 — ScanX Barrier Envelopes | Air Techniques, Inc. Jul 26, 2019 |
| K182384 — ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. Jul 26, 2019 |
| K190062 — STATCLAVE G4 Chamber Autoclave | Scican , Ltd. Jul 26, 2019 |
| K191211 — JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. Jul 25, 2019 |
| K190292 — Passio Pump Drainage System | Bearpac Medical Jul 25, 2019 |
| K190819 — Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions, Ltd. Jul 25, 2019 |
| K180845 — Maxima Electric System | Handpiece Headquarters - Hpr, Inc. Jul 25, 2019 |
| K191789 — Stonetome Stone Removal Device | Boston Scientific Corporation Jul 25, 2019 |
| K183017 — Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC Jul 25, 2019 |
| K190774 — RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Medos International SARL Jul 25, 2019 |
| K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage | Stryker Spine Jul 25, 2019 |
| K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular Jul 25, 2019 |
| K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model | Access Scientific, LLC Jul 25, 2019 |
| K190910 — PrisMax System Version 2 | Baxter Healthcare Corp Jul 25, 2019 |
| K182659 — Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems Jul 25, 2019 |
| K191100 — ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. Jul 24, 2019 |
| K190587 — Coolrail Linear Pen | AtriCure, Inc. Jul 24, 2019 |
| K182942 — Canon OCT-A1 | Canon, Inc. Jul 24, 2019 |
| K182984 — MaxiTears Contacts PF | Omnivision AG Jul 24, 2019 |
| K190678 — TempSure | Cynosure, Inc. Jul 24, 2019 |
| K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. Jul 24, 2019 |
| K191699 — Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co. , Ltd. Jul 24, 2019 |
| K190471 — 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. Jul 24, 2019 |
| K191662 — Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation Jul 23, 2019 |
| K190963 — DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | Synthes (USA) Products, LLC Jul 23, 2019 |