| K173573 — Tetric CAD | Ivoclar Vivadent, AG Jun 7, 2018 |
| K173155 — Pakter Curved Needle Set | Cook Incorporated Jun 7, 2018 |
| K172721 — FOCAL ONE | Edap Technomed, Inc. Jun 7, 2018 |
| K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | Genea Biomedx Pty, Ltd. Jun 7, 2018 |
| K172909 — ELEVARE, PERFECTIO 4 | Omm Imports D/B/A Zero Gravity Jun 7, 2018 |
| K180956 — Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co. , Ltd. Jun 7, 2018 |
| K181264 — QLAB Advanced Quantification Software | Philips Ultrasound, Inc. Jun 7, 2018 |
| K173032 — Paxman Scalp Cooler | Paxman Coolers Limited Jun 7, 2018 |
| K180459 — VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. Jun 7, 2018 |
| K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Jun 7, 2018 |
| K173577 — Guarded Luer Connector | International Medical Industries, Inc. Jun 7, 2018 |
| K180839 — AT 030 | Carl Zeiss Meditec, AG Jun 7, 2018 |
| K172121 — Digital Thermometer | Fudakang Industrial Co., Ltd. Jun 7, 2018 |
| K180122 — TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | Medtronic, Inc. Jun 7, 2018 |
| K180925 — uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. Jun 6, 2018 |
| K172221 — VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 | Taidoc Technology Corporation Jun 6, 2018 |
| K181207 — Balego TENS Digital Edition with Accessories for Pain Relief (OTC) | Everyway Medical Instruments Co., Ldt. Jun 6, 2018 |
| K180712 — Coconut Infused Hybrid Personal Lubricant | United Consortium Jun 6, 2018 |
| K180427 — ARK Fentanyl Assay | Ark Diagnostics, Inc. Jun 6, 2018 |
| K181202 — Sentry IVC Filter | Novate Medical , Ltd. Jun 6, 2018 |
| K180621 — EchoMark, EchoMark LP | Sonavex, Inc. Jun 6, 2018 |
| K172780 — SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. Jun 6, 2018 |
| K180832 — SALVATION External Fixation System | Wrightmedicaltechnologyinc Jun 6, 2018 |
| K180709 — truSculpt RF Device; truSculpt; truSculpt 3D | Cutera, Inc. Jun 6, 2018 |
| K180436 — T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | Stryker Trauma GmbH Jun 6, 2018 |
| K180926 — uMR 560 | Shanghai United Imaging Healthcare Co., Ltd. Jun 6, 2018 |
| K180672 — Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation Jun 6, 2018 |
| K173053 — POWDER FREE LATEX EXAMINATION GLOVE | Professional Latex Sdn Bhd Jun 6, 2018 |
| K172745 — ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. Jun 5, 2018 |
| K173961 — Straumann BLX Implant System | Institut Straumann AG Jun 5, 2018 |
| K173821 — LungQ Software | Thirona Corporation Jun 5, 2018 |
| K173093 — TAMA BEMS device | Tama Research Corporation Jun 5, 2018 |
| DEN170089 — Curve Positive Airway Pressure System | Fresca Medical Jun 5, 2018 |
| K173045 — Oximeter | Shenzhen Greatmade Tech Limited Jun 5, 2018 |
| K180661 — SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. Jun 5, 2018 |
| K180593 — Vbeam Prima Laser System | Syneron-Candela Jun 5, 2018 |
| K180608 — Lunoa System | Nightbalance BV Jun 5, 2018 |
| K180191 — SuperBall Meniscal Repair System | Arcuro Medical , Ltd. Jun 5, 2018 |
| K171609 — Check-Flo Performer Introducer Micropuncture Radial Artery Access Set | Cook Incorporated Jun 4, 2018 |
| K172807 — Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology Jun 4, 2018 |
| K172763 — Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | Zhejiang Kindly Medical Devices Co., Ltd. Jun 4, 2018 |
| K181012 — BUHLMANN fCAL ELISA | Buhlmann Laboratories AG Jun 4, 2018 |
| K180447 — reVive Light Therapy LED Cleansing System | Led Technologies, Inc. Jun 4, 2018 |
| K180500 — VariAx 2 System | Stryker GmbH Jun 4, 2018 |
| K180640 — SmartClip Soft Tissue Marker | Elucent Medical, Inc. Jun 4, 2018 |
| K180045 — Omnipod DASH Insulin Management System | Insulet Corporation Jun 1, 2018 |
| K180189 — InMode System with Fractora3D/3D-90 Applicators | Inmode MD , Ltd. Jun 1, 2018 |
| K180026 — Bowel Management Device, Bowel Management Irrigation Set | Applied Medical Technology, Inc. Jun 1, 2018 |
| K172068 — Kenz Cardico1211 | Suzuken Co., Ltd. Jun 1, 2018 |
| K172234 — Oxygen Concentrator | Sysmed (China) Co., Ltd. Jun 1, 2018 |