| K173576 — Pristina Serena | GE Healthcare May 14, 2018 |
| K173810 — Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics , Ltd. May 14, 2018 |
| K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | Myco Medical Supplies, Inc. May 14, 2018 |
| K180799 — Clarius Ultrasound Scanner | Clarius Mobile Health Corp. May 14, 2018 |
| K172640 — Dentium Implantium & SuperLine Prosthetics | Dentium Co., Ltd. May 14, 2018 |
| K180686 — SeaSpine Daytona Small Stature Spinal System | SeaSpine Orthopedics Corporation May 14, 2018 |
| K173758 — Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. May 14, 2018 |
| K172517 — SeaSpine Navigation System | SeaSpine Orthopedics Corporation May 11, 2018 |
| K172625 — Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | Nonin Medical, Inc. May 11, 2018 |
| K172570 — ALGS6 Ag Alginate Wound Dressing | Foshan United Medical Technologies, Ltd. May 11, 2018 |
| K173084 — Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation May 11, 2018 |
| K172510 — µCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation May 11, 2018 |
| K180383 — Light based hair removal device | Shenzhen Gsd Tech Co., Ltd. May 11, 2018 |
| K180409 — HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. May 11, 2018 |
| K180585 — Collagentex Rx-6 | Tanses Technologies, Inc. May 11, 2018 |
| K180287 — GSI Corti | Grason-Stadler, Inc. May 11, 2018 |
| K172719 — HealthBeacon HB2 Sharps Bin | Healthbeacon, Ltd. May 11, 2018 |
| K180385 — Infrared Body Thermometer | Hetaida Technology Co., Ltd. May 11, 2018 |
| K180727 — LineUp | Curvebeam, LLC May 11, 2018 |
| K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | Foremount Enterprise Co., Ltd. May 11, 2018 |
| K173264 — EmbryoScope+ | Vitrolife A/S May 11, 2018 |
| K180776 — Cytal Wound Particulate | Acell, Inc. May 11, 2018 |
| K172882 — UINCARE HOME | Uincare Corp. May 10, 2018 |
| K172867 — Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | Gmp Medicare Sdn Bhd (F25) May 10, 2018 |
| K180003 — FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. May 10, 2018 |
| K180625 — Rondek PGA Suture (Beige or Violet) | Rk Manufacturing Corporation May 10, 2018 |
| K180360 — OKTAGON Implant System | Hager& Meisinger GmbH May 10, 2018 |
| K180642 — Pro-Link® Ti Stand-Alone Cervical Spacer System | Life Spine, Inc. May 10, 2018 |
| K172583 — OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics, Inc. May 10, 2018 |
| K180937 — Graftgun Universal Graft Delivery System | SurGenTec, LLC May 10, 2018 |
| K173391 — OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC May 10, 2018 |
| K180961 — RadiForce MX194 | Eizo Corporation May 10, 2018 |
| K180101 — HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL May 10, 2018 |
| K173972 — 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC May 10, 2018 |
| K173012 — ANGIO-PRESS LITE DVT Compression Device | Pegasus Medical Supply, Inc. May 10, 2018 |
| K180279 — Silk'n MODEL H5003 device | Home Skinovations , Ltd. May 9, 2018 |
| K172145 — Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | Medela AG May 9, 2018 |
| K173311 — ARTHRO-Pump PA304 | W.O.M. World Of Medicine GmbH May 9, 2018 |
| K181032 — Halcyon | Varian Medical Systems, Inc. May 9, 2018 |
| K173309 — Faxitron VisionCT | Faxitron Bioptics, LLC May 9, 2018 |
| K180461 — Navi e/Navi s/Navi X Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. May 9, 2018 |
| K172191 — STERIZONE VP4 Sterilizer | Tso3, Inc. May 9, 2018 |
| K180929 — Klassic HD® Hip System | Total Joint Orthopedics, Inc. May 9, 2018 |
| K180913 — VSI Micro-Introducer Kit | Vascular Solutions, Inc. May 9, 2018 |
| K180932 — Diamond Orthopedic Bone Fixation Screws and Pins | Diamond Orthopedic, LLC May 9, 2018 |
| K173572 — DSM Biomedical Calcium Phosphate Cement with Microspheres | Kensey Nash Corporation Dba Dsm Biomedical May 9, 2018 |
| K173452 — EmboTrap ll Revascularization Device | Neuravi, Ltd. May 9, 2018 |
| K173202 — CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set | Sekisui Medical Co., Ltd. May 9, 2018 |
| K173347 — STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | Centinel Spine, Inc. May 8, 2018 |
| K172471 — VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. May 8, 2018 |