| K163568 — SHOFU RESIN GLAZE | Shofu Dental Corporation Aug 16, 2017 |
| K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | Carolina Liquid Chemistries Corporation Aug 15, 2017 |
| K170222 — Rapid Tox Cup II | American Bio Medica Corp. Aug 15, 2017 |
| K172374 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Aug 15, 2017 |
| K172163 — Eclipse Treatment Planning System | Varian Medical Systems, Inc. Aug 15, 2017 |
| K163483 — PANA SPRAY Plus | Nakanishi, Inc. Aug 15, 2017 |
| K171162 — Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | Prestige Ameritech Aug 15, 2017 |
| K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | Cair Lgl Aug 15, 2017 |
| K170872 — Aisys CS2 | Datex-Ohmeda, Inc. Aug 15, 2017 |
| K170321 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company Aug 14, 2017 |
| K163398 — ATLANTIS suprastructures | Dentsply Sirona Aug 14, 2017 |
| K171332 — Artemis Neuro Evacuation Device | Penumbra, Inc. Aug 14, 2017 |
| K170780 — ARIX Foot System (2.3/2.8) | Jeil Medical Corporation Aug 14, 2017 |
| K170492 — xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. Aug 11, 2017 |
| K161225 — Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. Aug 11, 2017 |
| K163166 — EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only | Easywell Biomedicals, Inc. Aug 11, 2017 |
| K171433 — Silk'n Infinity | Home Skinovations , Ltd. Aug 11, 2017 |
| K172122 — SOZO | ImpediMed Limited Aug 11, 2017 |
| K171657 — ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. Aug 11, 2017 |
| K170037 — Breathe Technologies Life2000 Ventilation System | Breathe Technologies Aug 11, 2017 |
| K163367 — GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. Aug 11, 2017 |
| K170624 — TalarLift STS | Fusion Orthopedics, LLC Aug 11, 2017 |
| K163625 — NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | Signature Orthopaedics Pty, Ltd. Aug 11, 2017 |
| K162977 — ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics Aug 11, 2017 |
| K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip | Cook Incorporated Aug 11, 2017 |
| K172140 — NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) | Polynovo Biomaterials Pty, Ltd. Aug 11, 2017 |
| K170574 — Diacap Pro Dialyzer | B. Braun Avitum AG Aug 11, 2017 |
| K171565 — OEC Elite | Ge Oec Medical Systems, Inc. Aug 10, 2017 |
| K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | 3M Healthcare Aug 10, 2017 |
| K171493 — MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. Aug 10, 2017 |
| K172114 — Zimmer Natural Nail System | Zimmer, Inc. Aug 10, 2017 |
| K170488 — Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr | Surge Cardiovascular Aug 10, 2017 |
| K171431 — HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | Biostable Science & Engineering, Inc. Aug 10, 2017 |
| K171200 — Grandio blocs | Voco GmbH Aug 10, 2017 |
| K171337 — LENSAR Laser System fs 3D (LLS-fs 3D) | Lensar, Inc. Aug 10, 2017 |
| K163121 — SmartUs EXT-1M/3M | Telemed Aug 10, 2017 |
| K172096 — Fraxis | Ilooda Co,., Ltd. Aug 9, 2017 |
| K172091 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | Centers For Disease Control And Prevention Aug 9, 2017 |
| K171809 — Epic Biliary Endoscopic Stent System | Boston Scientific Corporation Aug 9, 2017 |
| K171070 — WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Aug 9, 2017 |
| K170134 — Reperen Surgical Mesh | Iconlab, Inc. Aug 9, 2017 |
| K163167 — CKS Plus Knee System | Consensus Orthopedics, Inc. Aug 9, 2017 |
| K170060 — M22 and ResurFx Systems | Lumenis, Ltd. Aug 9, 2017 |
| K171071 — StimSox(TM) System | Stimmed, LLC Aug 9, 2017 |
| K172066 — DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. Aug 9, 2017 |
| K170787 — Powered Wheelchair DYW30A(D09) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. Aug 9, 2017 |
| K170827 — INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems Aug 9, 2017 |
| K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | Kerr Corporation Aug 8, 2017 |
| K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. Aug 8, 2017 |
| K172084 — Delta III Lithotripter | Dornier Medtech America, Inc. Aug 8, 2017 |