| K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set | Sol-Millennium Medical, Inc. Dec 3, 2018 |
| K173083 — IMPLANTER DENTAL PLANNING SOFTWARE | Implanter, LLC Dec 3, 2018 |
| K181908 — Action Trackchair | Action Manufacturing, Inc. Dec 3, 2018 |
| K181159 — LZI Fentanyl Enzyme Immunoassay | Lin-Zhi International, Inc. Dec 3, 2018 |
| K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. Dec 3, 2018 |
| K182336 — SubtlePET | Subtle Medical, Inc. Nov 30, 2018 |
| K180388 — Transcend 365 miniCPAP System | Somnetics International, Inc. Nov 30, 2018 |
| K182815 — XVWeb 3D | Apteryx, Inc. Nov 30, 2018 |
| K182245 — EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System | Edwards Lifesciences, LLC Nov 30, 2018 |
| K180792 — Arterial Pressure Monitoring Set/Tray | Cook Incorporated Nov 30, 2018 |
| K181221 — BD PhaSeal Optima Closed System Transfer Device | Becton, Dickinson And Company Nov 30, 2018 |
| K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | Vyaire Medical, Inc. Nov 30, 2018 |
| K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) Nov 30, 2018 |
| K181784 — Spectra S3 Plus | Uzinmedicare Co. Nov 30, 2018 |
| K173589 — Prizma | G-Medical Innovations , Ltd. Nov 30, 2018 |
| K181286 — Ambu aScope RLS Slim | Ambu A/S Nov 30, 2018 |
| K180482 — ZOLL Propaq M | ZOLL Medical Corporation Nov 30, 2018 |
| K182046 — Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System | Tyson Bioresearch, Inc. Nov 30, 2018 |
| K180298 — welloStationX | Wello, Inc. Nov 30, 2018 |
| DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Meridian Bioscience, Inc. Nov 30, 2018 |
| K182218 — FerriSmart Analysis System | Resonance Health Analysis Services Pty, Ltd. Nov 30, 2018 |
| K182600 — Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | Better Care Plastic Technology Co., Ltd. Nov 30, 2018 |
| K180918 — Planmed Verity | Planmed OY Nov 30, 2018 |
| K183023 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. Nov 30, 2018 |
| K181696 — ChitoZolve | Gyrus Acmi, Inc. Nov 30, 2018 |
| K173495 — Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. Nov 30, 2018 |
| K182249 — Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Bausch & Lomb, Incorporated Nov 30, 2018 |
| K180495 — Tinnitus Sound Generator Module | GN Hearing A/S Nov 30, 2018 |
| K182797 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL | Thermo Fisher Scientific Nov 30, 2018 |
| K182663 — Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | Finemec Co., Ltd. Nov 30, 2018 |
| K183030 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. Nov 30, 2018 |
| K181588 — POPS! one Blood Glucose Monitoring System | Taidoc Technology Corporation Nov 30, 2018 |
| K182498 — Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. Nov 30, 2018 |
| K180840 — UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. Nov 30, 2018 |
| K181427 — BD MAX Enteric Viral Panel, BD MAX Instrument | Becton, Dickinson And Company Nov 29, 2018 |
| K181667 — Thoraguard System | Centese, Inc. Nov 29, 2018 |
| K181880 — VivaSight-SL (TVT) system | Etview , Ltd. Nov 29, 2018 |
| K182988 — Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS Nov 29, 2018 |
| K182587 — Device Electrosurgical Generator ESG-150 | Olympus Winter & Ibe GmbH Nov 29, 2018 |
| K173701 — Implant-One System | Implant Logistics, Inc. Nov 29, 2018 |
| K182047 — Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System | Tyson Bioresearch, Inc. Nov 29, 2018 |
| K182181 — Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation Nov 29, 2018 |
| K182757 — Espire Elbow Pro, Espire Elbow Hybrid | College Park Industries, Inc. Nov 29, 2018 |
| K182418 — V3 Segmental Plating System | Atlas Spine, Inc. Nov 29, 2018 |
| K180685 — AS-3XX Series Fingertip Pulse Oximeter | Xiamen Acurio Instruments Co., Ltd. Nov 29, 2018 |
| K181816 — Ceramic Denture Zirconia Ceramics Block | Qinhuangdao Silide Ceramic Technology Co., Ltd. Nov 29, 2018 |
| K180665 — SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2M, LLC Nov 28, 2018 |
| K181693 — SMS Femoral Stem | Medacta International S.A. Nov 28, 2018 |
| K182992 — BGM014 Blood Glucose Monitoring System | Apex BioTechnology Corp. Nov 28, 2018 |
| K180498 — NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated Nov 28, 2018 |