| K180703 — VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. Aug 1, 2018 |
| K181749 — SuperCable® Iso-Elastic Cerclage System | Kinamed, Incorporated Aug 1, 2018 |
| K180647 — BriefCase | Aidoc Medical , Ltd. Aug 1, 2018 |
| K181666 — Smart One | Mir Medical International Research Aug 1, 2018 |
| DEN180008 — MolecuLight i:X | MolecuLight, Inc. Jul 31, 2018 |
| K181272 — Picocare Family | Wontech Co., Ltd. Jul 31, 2018 |
| K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | Spr Therapeutics, Inc. Jul 31, 2018 |
| K181708 — MTS Plazomicin 0.016-256 µg/mL | Liofilchem S.R.L. Jul 31, 2018 |
| K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | 3M Healthcare Jul 31, 2018 |
| K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | Siemens Healthcare Diagnostics, Inc. Jul 30, 2018 |
| K181720 — Epiphany Cardio Server Mobile | Epiphany Healthcare, LLC Jul 30, 2018 |
| K181440 — Proficient® Posterior Cervical Spine System | Spine Wave, Inc. Jul 30, 2018 |
| K181431 — Laser Ureteral Catheter | Cook Incorporated Jul 30, 2018 |
| K181741 — IceSphere 1.5 CX Cryoablation Needle | Galil Medical , Ltd. Jul 30, 2018 |
| K180912 — TE7/TE5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 30, 2018 |
| K172273 — 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. Jul 30, 2018 |
| K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, | Centers For Disease Control And Prevention (CDC) Jul 30, 2018 |
| K173474 — RetiCapture | Ilooda Co,., Ltd. Jul 27, 2018 |
| K180076 — Ti 3Z Interbody System | Zavation Medical Products, LLC Jul 27, 2018 |
| K180580 — Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices | Surgical Instrument Service And Savings, Inc. Jul 27, 2018 |
| K173808 — Voutia | Jeffrey Ward Cash, Dds Jul 27, 2018 |
| K181554 — Stowe Pedicle Screw System | Black Box Medical Jul 27, 2018 |
| K181452 — RCT800 | Ray Co., Ltd. Jul 27, 2018 |
| K180064 — OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. Jul 27, 2018 |
| K181395 — Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. Jul 27, 2018 |
| K172616 — Pulse Oximeter | Beijing Safe Heart Technology , Ltd. Jul 27, 2018 |
| K180627 — Macroduct Advanced Model 3710 | Elitechgroup, Inc. Jul 27, 2018 |
| K181763 — FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation Jul 27, 2018 |
| K181694 — FlowTriever Retrieval/Aspiration System | Inari Medical Jul 27, 2018 |
| K181485 — EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. Jul 27, 2018 |
| K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | Covidien, LLC Jul 27, 2018 |
| K180556 — Corelink Foundation 3D Anterior Lumbar System | Corelink, LLC Jul 27, 2018 |
| K181156 — Panther Fusion GBS Assay | Diagenode Jul 27, 2018 |
| K181184 — OIC Intramedullary Nail System | The Orthopaedic Implant Company Jul 27, 2018 |
| K181268 — PROLENE (Polypropylene) 3D Patch | ETHICON, Inc. Jul 26, 2018 |
| K181855 — RadialSeal Introducer Kit | Great Batch Medical Jul 26, 2018 |
| K173107 — Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. Jul 26, 2018 |
| K181712 — San Antonio Stopcock | Cook Incorporated Jul 26, 2018 |
| K181579 — eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K | E&E Optics, Inc. Jul 26, 2018 |
| K181699 — Level 1 Convective Warmer | Smiths Medical Asd, Inc. Jul 26, 2018 |
| K173656 — Arthrex FibuLock Nail | Arthrex, Inc. Jul 26, 2018 |
| K181706 — neuromate Gen III | Renishaw Mayfield Sarl Jul 26, 2018 |
| K181659 — Avologi ENEO | Premier North America, Inc. Jul 26, 2018 |
| K180272 — Saniclave 250 | Revolutionary Science Jul 26, 2018 |
| K180958 — Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Shockwave Medical, Inc. Jul 26, 2018 |
| K181401 — RxSight Insertion Device | Rxsight, Inc. Jul 26, 2018 |
| K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. Jul 26, 2018 |
| K181453 — ATEC ALIF Spacer System | Alphatec Spine, Inc. Jul 25, 2018 |
| K180226 — TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. Jul 25, 2018 |
| K180960 — FIXIT / ComposiTCP Threaded Anchor System | S.B.M. Sas Sciences For Bio Materials Jul 25, 2018 |