| K181216 — HAMILTON-T1, HAMILTON-C1 | Hamilton Medical AG Aug 2, 2019 |
| K183091 — Elaris Pedicle Screw System | Spinewelding AG Aug 2, 2019 |
| K183088 — ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited Aug 2, 2019 |
| K191505 — Rezum System | Nxthera (A Boston Scientific Company) Aug 2, 2019 |
| K191143 — PowerFlow Implantable Apheresis IV Port | C.R. Bard, Inc. Aug 2, 2019 |
| K190090 — DynoSense Vital Sign Measuring System | Dynosense Corp. Aug 2, 2019 |
| K190293 — Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. Aug 2, 2019 |
| K191217 — JAZZ PF | Implanet, S.A. Aug 2, 2019 |
| K191190 — Steerable Introducer | Freudenberg Medical, LLC Aug 1, 2019 |
| K183590 — Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip | Olympus Medical Systems Corp. Aug 1, 2019 |
| K190887 — Leksell Vantage Stereotactic System | Elekta Instrument AB Aug 1, 2019 |
| K190176 — MINAMO | Asahi Intecc Co., Ltd. Aug 1, 2019 |
| K191469 — Biotronik Stylets | Biotronik, Inc. Aug 1, 2019 |
| K191192 — SurgTech GENOLL Total Knee System | Surgtech, Inc. Aug 1, 2019 |
| K191267 — ImagingRing System on Rails | Medphoton GmbH Aug 1, 2019 |
| K183193 — MREplus+ Software | Resoundant, Inc. Aug 1, 2019 |
| K182818 — LOQTEQ VA Calcaneus Plate 3.5 | Aap Implantate AG Aug 1, 2019 |
| K182871 — Mini TENS Therapy Device | Shenzhen Jumper Medical Equipment Co., Ltd. Aug 1, 2019 |
| K191214 — JO Premium Jelly Original Personal Lubricant | United Consortium Aug 1, 2019 |
| K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | United States Endoscopy Group, Inc. Aug 1, 2019 |
| K191499 — MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. Aug 1, 2019 |
| K190891 — Fluobeam LX | Fluoptics Jul 31, 2019 |
| K191773 — GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. Jul 31, 2019 |
| K190777 — DemeTECH DemeFORCE Nonabsorbable Surgical Suture | Demetech Corporation Jul 31, 2019 |
| K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | Medtronic Navigation, Inc. Jul 31, 2019 |
| K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae | Hycor Biomedical Jul 31, 2019 |
| K190732 — P200TxE | Optos Plc. Jul 31, 2019 |
| K191795 — AOCup Lens Case with AODisc | Alcon Laboratories, Inc. Jul 31, 2019 |
| K191183 — EyeBOX | Oculogica, Inc. Jul 31, 2019 |
| K191761 — Mobius3D | Varian Medical Systems, Inc. Jul 31, 2019 |
| K191764 — Inion BioRestore | Inion OY Jul 31, 2019 |
| K191611 — Diode Laser Therapy Systems | Wingderm Electro-Optics , Ltd. Jul 31, 2019 |
| K191931 — HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | Hardy Diagnostics Jul 31, 2019 |
| K191768 — AXS Vecta Aspiration System | Stryker Neurovascular Jul 30, 2019 |
| K183288 — Transcutaneous Electrical Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. Jul 30, 2019 |
| K191454 — Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. Jul 30, 2019 |
| K190274 — Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. Jul 30, 2019 |
| K182089 — Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs | Platinum Glove Industries Sdn. Bhd. Jul 30, 2019 |
| K180295 — Hamilton-G5 | Hamiton Medical AG Jul 30, 2019 |
| K190291 — Addivation Medical Cervical Interbody System | Addivation Medical, LLC Jul 30, 2019 |
| K190132 — Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic Jul 30, 2019 |
| K181743 — Blood Transfer Accessory (BTA) | Nsp Tech Pte, Ltd. Jul 30, 2019 |
| K181754 — Blood Collection Accessory (BUCA) | Nsp Tech Pte, Ltd. Jul 30, 2019 |
| K191484 — Renuvion/J-Plasma Precise Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) Jul 30, 2019 |
| K183547 — Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic Jul 30, 2019 |
| K190339 — Helioseal F Plus | Ivoclar Vivadent, AG Jul 29, 2019 |
| K191535 — CoLink® Mini Plating System | In2Bones USA, LLC Jul 29, 2019 |
| K191136 — Access CT | Philips Healthcare (Suzhou) Co., Ltd. Jul 29, 2019 |
| K190886 — Non-invasive blood pressure measurement systems | Joytech Healthcare Co. , Ltd. Jul 29, 2019 |
| K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Zeus Scientific, Inc. Jul 29, 2019 |