| K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. Oct 4, 2019 |
| K192128 — Sutter Arrowtip Monopolar Electrodes | Sutter Medizintechnik GmbH Oct 4, 2019 |
| K183441 — Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | Semperit Investments Asia Pte , Ltd. Oct 4, 2019 |
| K191713 — CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Omega Medical Imaging, LLC Oct 4, 2019 |
| K190183 — Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Oct 4, 2019 |
| K192448 — Delta Xtend Revers Shoulder System | Depuy(Ireland) Oct 4, 2019 |
| K192433 — LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. Oct 4, 2019 |
| K192422 — Steerable Introducer 12F | Freudenberg Medical, LLC Oct 4, 2019 |
| K191994 — ProFound AI Software V2.1 | Icad, Inc. Oct 4, 2019 |
| K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | Beckman Coulter Biomedical GmbH Oct 4, 2019 |
| K191843 — Ceramill A-Temp | Amann Girrbach AG Oct 4, 2019 |
| K190591 — Safergel Sterile Ultrasound Gel | Safersonic Us, Inc. Oct 4, 2019 |
| K183710 — Vivio System | Avicena, LLC Oct 4, 2019 |
| K190060 — Urethrotech UCD | Urethrotech Oct 4, 2019 |
| K183479 — Asthma Monitor AM3 | Eresearch Technology Oct 3, 2019 |
| K192398 — Millenium HX | Mar Cor Purification, Inc. Oct 3, 2019 |
| K191490 — Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe | Jiangsu Caina Medical Co.,Ltd Oct 3, 2019 |
| K192318 — Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. Oct 3, 2019 |
| K192400 — EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | DRTECH Corporation Oct 3, 2019 |
| K192427 — Ablation Confirmation | Neuwave Medical, Inc. Oct 3, 2019 |
| K191344 — Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module | Arthrex, Inc. Oct 3, 2019 |
| K192424 — Mobius3D | Varian Medical Systems, Inc. Oct 3, 2019 |
| K191806 — Propex IQ Apex Locator | Dentsply Sirona Oct 3, 2019 |
| K182143 — ALFA GATE Dental Implants System | Alfa Gate Mazen, Ltd. Oct 3, 2019 |
| K191332 — XACT Robotic System | Xact Robotics, Ltd. Oct 3, 2019 |
| K190179 — SAHARA Stabilization System | K2M, Inc. Oct 3, 2019 |
| K191794 — Vintage Art Universal | Shofu Dental Corporation Oct 3, 2019 |
| K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | Atlas Medical Oct 3, 2019 |
| K191993 — Yumizen C1200 CRP | HORIBA ABX SAS Oct 3, 2019 |
| K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare Oct 3, 2019 |
| K191066 — CD Horizon Astute Spinal System | Medtronic Sofamor Danek USA, Inc. Oct 3, 2019 |
| K191932 — Momentum Posterior Spinal Fixation System | Ulrich Medical USA Oct 2, 2019 |
| K191397 — OxySoft (olifilcon C) silicone hydrogel soft contact lens | Visco Vision, Inc. Oct 2, 2019 |
| K190820 — Aimanfun Lumea Comfort | Kam Yuen Plastic Products , Ltd. Oct 2, 2019 |
| K191363 — Neocis Planning Software Application (NPSA) for 3rd Party PCs | Neocis, Inc. Oct 2, 2019 |
| K191889 — NG-Test CARBA 5 | Ng Biotech Oct 2, 2019 |
| K192064 — LIAISON Vitamin B12 | DiaSorin, Inc. Oct 2, 2019 |
| K191958 — Aveta System | Meditrina, Inc. Oct 1, 2019 |
| K192303 — ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. Oct 1, 2019 |
| K192416 — BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH Oct 1, 2019 |
| K191526 — Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. Oct 1, 2019 |
| K191507 — Intellijoint® Navigation System | Intellijoint Surgical, Inc. Oct 1, 2019 |
| K191610 — RTapp | Segana, LLC Oct 1, 2019 |
| K192426 — Signa Voyager, Signa Voyager Quantum | Ge Healthcare (Tianjin) Company Limited Oct 1, 2019 |
| K183462 — Applied Biosystems Bacillus anthracis Detection Kit | Mriglobal Oct 1, 2019 |
| K192453 — DIAMOND-5A/6A/8A | DRGEM Corporation Oct 1, 2019 |
| K192425 — Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | Wontech Co., Ltd. Sep 30, 2019 |
| K191774 — SmileAlign Orthodontic Aligner System | 3D Global Biotech, Inc. Sep 30, 2019 |
| K190048 — UF(II) Anatomic abutment | Dio Corporation Sep 30, 2019 |
| K191848 — APTUS Wrist Spanning Plates 2.5 | Medartis AG Sep 30, 2019 |