| K173825 — MC 300R* Nebulizer | Trudell Medical International May 2, 2018 |
| K180796 — Spineology Navigation Instruments | Spineology, Inc. May 2, 2018 |
| K180599 — Venue | GE Medical Systems Ultrasound And Primary Care Diagnostics May 2, 2018 |
| K180352 — 7D Surgical System | 7D Surgical, Inc. May 2, 2018 |
| K172409 — Lite | Tzora Active Systems , Ltd. May 2, 2018 |
| K180264 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics May 2, 2018 |
| K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated May 2, 2018 |
| K172864 — Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Maxter Glove Manufacturing Sdn Bhd May 2, 2018 |
| K180848 — AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | ArthroCare Corporation May 1, 2018 |
| K172554 — LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing | Huizhou Foryou Medical Devices Co., Ltd. May 1, 2018 |
| K172412 — BacterioScan 216Dx System | Bacterioscan, Inc. May 1, 2018 |
| K172656 — BiliLux | Draeger Medical Systems, Inc. May 1, 2018 |
| K172959 — PeraServer and PeraTrend | Perahealth, Inc. May 1, 2018 |
| K172555 — SAPPHIRE, ELEVARE SAPPHIRE | Omm Imports, Inc. D/B/A Zero Gravity May 1, 2018 |
| K173035 — Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | Cook Incorporated May 1, 2018 |
| K173300 — ViaTherm BOOST | Viatherm Therapeutics, LLC May 1, 2018 |
| K173718 — Liberty Cycler Set | Fresenius Medical Care Renal Therapies Group, LLC May 1, 2018 |
| K180307 — Mazor X | Mazor Robotics , Ltd. Apr 30, 2018 |
| K172636 — VitaMESH Macroporous PP Surgical Mesh | Proxy Biomedical , Ltd. Apr 30, 2018 |
| K173304 — Finessis Intense Polyisoprene Surgical Glove | Lucenxia Prescience AG Apr 30, 2018 |
| K180636 — ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. Apr 30, 2018 |
| K180696 — Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) | Medline Industries, Inc. Apr 30, 2018 |
| K172726 — EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | Olympus Medical Systems Corp. Apr 30, 2018 |
| K171678 — Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable | Vyaire Medical, Inc. Apr 30, 2018 |
| K180069 — HDR MRI Lumen Marker | C4 Imaging, LLC Apr 27, 2018 |
| K172258 — Novasight Hybrid System | Conavi Medical, Inc. Apr 27, 2018 |
| K172747 — HYALURONIC ACID TOPICAL WOUND CREAM | Virchow Biotech Pvt, Ltd. Apr 27, 2018 |
| K172460 — ADHEAR System | Med-El Elektromedizinische Geraete GmbH Apr 27, 2018 |
| K180669 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal | Alcon Laboratories, Inc. Apr 27, 2018 |
| K172764 — Keymill | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) Apr 27, 2018 |
| K172866 — NeuroCap | Memory MD, Inc. Apr 27, 2018 |
| K172720 — TRACOE silcosoft Tracheostomy Tube | Tracoe Medical GmbH Apr 27, 2018 |
| K180154 — QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. Apr 27, 2018 |
| K173390 — hipEOS | Onefit Medical Apr 27, 2018 |
| K171151 — ACRON TLIF System | Spinemed Ges.M.B.H Apr 27, 2018 |
| K172166 — OLYMPIC Navigated Instruments | Astura Medical Apr 27, 2018 |
| K171821 — 2 Face / Face Evolution | Heat IN A Click Apr 26, 2018 |
| K172955 — LungVision Tool | Bodyvision Medical , Ltd. Apr 26, 2018 |
| K180548 — 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology | C.R. Bard, Inc (Bard Has Joined Bd) Apr 26, 2018 |
| K173201 — UNITY Sacroiliac Joint Fixation System | Huvexel Co. , Ltd. Apr 26, 2018 |
| K180200 — ESG-300, APU-300, Pressure Reducer, MAPC Probes | Olympus Winter & Ibe GmbH Apr 26, 2018 |
| K173398 — Xpert Xpress Strep A | Cepheid Apr 26, 2018 |
| K171872 — P50 Series Dental Operative Unit and Accessories | Pelton & Crane Apr 26, 2018 |
| K172875 — Astral 100/150 | Resmed, Ltd. Apr 26, 2018 |
| K170339 — Summit Hip System | DePuy Orthopaedics, Inc. Apr 26, 2018 |
| K180433 — ENNOVATE® | Aesculap Implant Systems, LLC Apr 26, 2018 |
| K172923 — Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | Top Glove Sdn. Bhd. Apr 26, 2018 |
| K172633 — INFINITY Total Ankle System | Wrightmedicaltechnologyinc Apr 26, 2018 |
| DEN170028 — Cala ONE | Cala Health, Inc. Apr 26, 2018 |
| K173337 — Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. Apr 26, 2018 |