| K173516 — NuBorne Infant Warmer | International Biomedical Aug 17, 2018 |
| K181074 — Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC Aug 17, 2018 |
| K180574 — Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor | J & J Solutions, Inc. D/B/A/ Corvida Medical Aug 17, 2018 |
| K173608 — Forest Dental Unit | Forest Dental Products, Inc. Aug 17, 2018 |
| K181943 — OSCAR (OSCAR Prime, OSCAR Classic) | Genoray Co., Ltd. Aug 17, 2018 |
| K173509 — Biodegradable Nitrile Powder Free Examination Glove (Blue) | Hartalega Sdn Bhd Aug 17, 2018 |
| K181767 — Cios Select | Siemens Medical Solutions USA, Inc. Aug 17, 2018 |
| K173575 — OsteoReady Dental Implant System | Osteoready, LLC Aug 17, 2018 |
| K181713 — Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated Aug 17, 2018 |
| K181966 — SmartPerfusion | Philips Medical Systems Nederlands B.V. Aug 17, 2018 |
| K181306 — Actifuse Flow | Baxter Healthcare Corporation Aug 17, 2018 |
| K181983 — PreXion 3D Excelsior | Prexion Corporation Aug 17, 2018 |
| K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. Aug 17, 2018 |
| K173773 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | Bayer Medical Care, Inc. Aug 17, 2018 |
| K173761 — Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. Aug 17, 2018 |
| K180974 — CBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. Aug 17, 2018 |
| K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | Bionime Corporation Aug 17, 2018 |
| K173257 — BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. Aug 17, 2018 |
| K181923 — Quantum Workstation 12.1 | Spectrum Medical , Ltd. Aug 17, 2018 |
| K180943 — BioWaveGO | Biowave Corporation Aug 17, 2018 |
| K172492 — Optical Topography System ETG-4100 | Hitachi Healthcare Americas Aug 17, 2018 |
| DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | Brainways , Ltd. Aug 17, 2018 |
| K173663 — Electronic Stethoscope DS3011A | Imediplus, Inc. Aug 17, 2018 |
| K173918 — VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International Aug 17, 2018 |
| K181020 — Cytosponge Cell Collection Device | Covidien, LLC Aug 16, 2018 |
| K180522 — IGTFusion | Igi Technologies Aug 16, 2018 |
| K180619 — Bongo | Innomed Healthscience, Inc. Aug 16, 2018 |
| K181206 — GentleCath Glide Intermittent Urinary Catheter | Convatec Limited Aug 16, 2018 |
| K173454 — Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co.,Ltd Aug 16, 2018 |
| K180077 — NeuroQ 3.8 | Syntermed Aug 16, 2018 |
| K181909 — Luminelle DTx Hysteroscopy System | Uvision360, Inc. Aug 16, 2018 |
| K181289 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | Cepheid Aug 15, 2018 |
| K180428 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Aug 15, 2018 |
| K181592 — RAIN Sheath Transradial | Cordis Corporation Aug 15, 2018 |
| K181347 — Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC Aug 15, 2018 |
| K181308 — SuperGrow 272, Ultimate 272 | Super Grow Lasers Aug 15, 2018 |
| K181407 — Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. Aug 15, 2018 |
| K181500 — BRILLIANT Crios | Coltene/Whaledent AG Aug 15, 2018 |
| K181359 — InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC Aug 15, 2018 |
| K181711 — BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | Microbiologics, Inc. Aug 15, 2018 |
| K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. Aug 15, 2018 |
| K181676 — Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works Aug 15, 2018 |
| K181977 — WiScope Digital Endoscope System | OTU Medical, Inc. Aug 14, 2018 |
| K182067 — PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. Aug 14, 2018 |
| K181414 — uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. Aug 14, 2018 |
| K180131 — Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen Of Troy Company Aug 14, 2018 |
| K181792 — Duo Lumbar Interbody Fusion Device | Spineology, Inc. Aug 14, 2018 |
| K173620 — Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S Aug 14, 2018 |
| K180962 — KLS Martin Individual Patient Solutions | KLS-Martin L.P. Aug 13, 2018 |
| K180990 — TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. Aug 13, 2018 |