| K171798 — Silverwear Silver Pro Garment Device | Media Plus, LLC Jun 1, 2018 |
| K173330 — PanNAT STEC Test | Micronics, Inc. Jun 1, 2018 |
| K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus Jun 1, 2018 |
| K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters | Smiths Medical Asd, Inc. Jun 1, 2018 |
| K172499 — NEOSHIELD | JMS North America Corporation Jun 1, 2018 |
| K173975 — UF(II) Wide Fixture | Dio Corporation Jun 1, 2018 |
| K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | Kci USA, Inc. Jun 1, 2018 |
| K180617 — Hair Up | Y & J Bio Co., Ltd. Jun 1, 2018 |
| K180238 — CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. Jun 1, 2018 |
| K172765 — Smart Moves Complete | Great Lakes Orthodontics, Ltd. Jun 1, 2018 |
| K180325 — Single Use MultiClip Device | Micro-Tech (Nanjing) Co., Ltd. Jun 1, 2018 |
| K180136 — BioNude Lubricant | Good Clean Love, Inc. Jun 1, 2018 |
| K170703 — Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Limited May 31, 2018 |
| K180480 — ATEC Universal Spacer System | Alphatec Spine, Inc. May 31, 2018 |
| K181177 — Interventional Workspot | Philips Medical Systems Nederland B.V. May 31, 2018 |
| K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. May 31, 2018 |
| K181122 — CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. May 31, 2018 |
| K180582 — Sternal Cable System | A & E Medical Corporation May 31, 2018 |
| K180464 — AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. May 31, 2018 |
| K180606 — SOMAVAC Device | Somavac Medical Solutions, Inc. May 31, 2018 |
| K172690 — ToFscan | Idmed May 31, 2018 |
| K171828 — ETCO2 Sensor | Orantech, Inc. May 31, 2018 |
| K181098 — ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. May 31, 2018 |
| K173415 — EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. May 31, 2018 |
| K180167 — Playtex Stella Tampons | Playtex Manufacturing, Inc. May 30, 2018 |
| K180361 — MICRORAPTOR REGENESORB Suture Anchor | Smith And Nephew, Inc. May 30, 2018 |
| K173483 — Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC May 30, 2018 |
| K181188 — EVEREST Spinal System | K2M, Inc. May 30, 2018 |
| K173269 — KATOR Suture Anchor | Kator, LLC May 30, 2018 |
| K173951 — Legend Acetabular Liners | Ortho Development Corporation May 30, 2018 |
| K180293 — Retia 2 | Centervue S.P.A. May 30, 2018 |
| K173246 — ANEROID SPHYGMOMANOMETER | Wenzhou Bokang Instruments Co., Ltd. May 30, 2018 |
| K171019 — ScioCardio ECG Transmitter | Synergen Technology Labs, LLC May 30, 2018 |
| K172825 — MN-111 | W&H Sterilization S.R.L. May 30, 2018 |
| K173157 — Dr's Light2 | Good Doctors Co., Ltd. May 29, 2018 |
| K180553 — VERIFY Spore Test Strip for S40 Sterilant | STERIS Corporation May 29, 2018 |
| K181132 — Tri-Ad 2.0 Adams Tricuspid Band | Medtronic May 29, 2018 |
| K180174 — Belun Ring | Belun Technology Company Limited May 29, 2018 |
| K172871 — SpineKure Kyphoplasty System | Hanchang Co., Ltd. May 29, 2018 |
| K180572 — AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | Supersonic Imagine May 29, 2018 |
| K180356 — inui In-Home Urine Analysis Test System | Scanadu, Inc. May 25, 2018 |
| K172889 — Infrared Thermometer | Shenzhen Pacom Medical Instruments Co., Ltd. May 25, 2018 |
| K180711 — FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation May 25, 2018 |
| K173834 — Quantum Pump Console | Spectrum Medical , Ltd. May 25, 2018 |
| K172717 — Automatic Tissue Processing Unit | Bsl Co. May 25, 2018 |
| K172147 — STAR 65 | Skanray Technologies Pvt, Ltd. May 25, 2018 |
| K180163 — TransEnterix Senhance Surgical System | Transenterix, Inc. May 25, 2018 |
| K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | Topcon Medical Laser Systems, Inc. May 25, 2018 |
| K172242 — DripAssist Plus | Shift Labs, Inc. May 25, 2018 |
| K180111 — ClearGuard HD Antimicrobial Barrier Cap | Pursuit Vascular, Inc. May 25, 2018 |