| K180673 — Normandy VBR System | Zavation Medical Products, LLC Jul 13, 2018 |
| K171880 — IRRAflow CNS System | Irras, Inc. Jul 13, 2018 |
| K171550 — Sterile Latex Surgical Gloves, Powder Free | Sanrea Healthcare Products Pvt, Ltd. Jul 13, 2018 |
| K172987 — Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. Jul 13, 2018 |
| K173340 — Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. Jul 13, 2018 |
| K173556 — Injection Screw | Biedermann Medtech, Inc. Jul 13, 2018 |
| K180655 — Viking Lumbar Polyaxial Screw System | Presidio Surgical Jul 13, 2018 |
| K181586 — Tinnitus Sound Generator Module | GN Hearing A/S Jul 13, 2018 |
| K181063 — Kestrel Buttress Plate System | Innovasis, Inc. Jul 13, 2018 |
| K172440 — Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 | Dongguan Prestige Sporting Goods., Ltd. Jul 13, 2018 |
| K181276 — CONOD Enteral Feeding Sets | Conod Medical Co., Limited Jul 12, 2018 |
| K181043 — StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation Jul 12, 2018 |
| K180552 — Modified Novy Cornual Cannulation Set | Cook Incorporated Jul 12, 2018 |
| K181011 — AIM2 | GC America, Inc. Jul 12, 2018 |
| K180695 — FBC 921 (ALIF) | Fbc Device Aps Jul 12, 2018 |
| K172874 — Infrared Thermometer | Shenzhen Jiacom Technology CO ., Ltd. Jul 12, 2018 |
| K180613 — Estelite Universal Flow | Tokuyama Dental Corporation Jul 12, 2018 |
| K173206 — SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. Jul 12, 2018 |
| K181287 — Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. Jul 12, 2018 |
| K180575 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X | Olympus Medical Systems Corp. Jul 12, 2018 |
| K173627 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service And Savings, Inc. Jul 12, 2018 |
| K173511 — ActiveCare TD-4121 Blood Glucose Monitoring System | Taidoc Technology Corporation Jul 12, 2018 |
| K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. Jul 12, 2018 |
| K173631 — Intelli-C | Nrt X-Ray A/S Jul 11, 2018 |
| K172543 — High-speed Turbine Handpieces for Single Use | Beijing Dongbo Dental Handpiece Co., Ltd. Jul 11, 2018 |
| K173486 — NTU-USB Ultrasound USB Box | National Taiwan University Jul 11, 2018 |
| K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. Jul 11, 2018 |
| K181697 — 16ch Foot/ Ankle SPEEDER | Quality Electrodynamics, LLC Jul 11, 2018 |
| K180314 — Infrared Thermometer | Xuzhou Yongkang Electronic Science Technology Co., Ltd. Jul 11, 2018 |
| K180730 — INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc Jul 11, 2018 |
| K180967 — Dental Diode Laser System | Lazon Medical Laser Co., Ltd. Jul 11, 2018 |
| K181523 — Syneron CO2RE System | Syneron-Candela Corp Jul 11, 2018 |
| K180024 — SALVATION Midfoot Nail | Wrightmedicaltechnologyinc Jul 11, 2018 |
| K180963 — ROCCIA ALIF, ROCCIA TLIF | Silony Medical GmbH Jul 11, 2018 |
| K180816 — Ziehm RFD 3D Tracker | Medtronic Navigation Jul 11, 2018 |
| K173801 — Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. Jul 11, 2018 |
| K173881 — Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | Owen Mumford, Ltd. Jul 11, 2018 |
| K180725 — Aspire Introducer Needle | Aspire Bariatrics, Inc. Jul 11, 2018 |
| K180970 — Disposable guides KDNG00 | Koelis Jul 10, 2018 |
| K181574 — Uscan | EchoNous, Inc. Jul 10, 2018 |
| K181201 — Synermed ISE Reagents | Infrared Laboratory Systems, LLC (Dba Synermed) Jul 10, 2018 |
| K173039 — TruMatch CMF Titanium 3D Printed Implant | Materialise NV Jul 10, 2018 |
| K180900 — LED Light Therapy Device | Uvbiotek, LLC Jul 10, 2018 |
| K181244 — Zavation Cervical Plate System | Zavation Medical Products, LLC Jul 10, 2018 |
| K180697 — Pseudo-Patient | Rtsafe, Inc. Jul 10, 2018 |
| K181246 — Zavation IBF System | Zavation Medical Products, LLC Jul 10, 2018 |
| K173274 — Ceevra Reveal 2.0 | Ceevra, Inc. Jul 10, 2018 |
| K181700 — HardyDisk AST Plazomicin 30ug (PLZ30) | Hardy Diagnostics Jul 10, 2018 |
| K181572 — Workflow Box | Mirada Medical, Ltd. Jul 10, 2018 |
| K172991 — Advanced Dental Applicance | Dasoft Partners Jul 10, 2018 |