| K173005 — SURECELL Gelling Fiber Wound Dressing | Jiangsu Newvalue Medical Producst Co.,Ltd May 25, 2018 |
| K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. May 25, 2018 |
| K181150 — ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. May 25, 2018 |
| K173914 — VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc. May 25, 2018 |
| K180543 — GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. May 24, 2018 |
| K180862 — Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. May 24, 2018 |
| K172708 — T2Bacteria Panel | T2Biosystems, Inc. May 24, 2018 |
| K170697 — GBR system | Surgident May 24, 2018 |
| K181136 — CS 9600 | Trophy May 24, 2018 |
| K180756 — Safety Wire Guide Introducer | Cook Incorporated May 24, 2018 |
| K181077 — ActiGraph CentrePoint Insight Watch | Actigraph May 24, 2018 |
| K172665 — Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | Wilson-Cook Medical Inc./Cook Endoscopy May 24, 2018 |
| K180414 — EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. May 24, 2018 |
| K180807 — Celling Aspiration Needle | Spine Smith Holdings, LLC May 24, 2018 |
| K173938 — IS-III HActive Fixture | Neobiotech Co., Ltd. May 24, 2018 |
| DEN180005 — OsteoDetect | Imagen Technologies, Inc. May 24, 2018 |
| K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | Euroimmun Us, Inc. May 24, 2018 |
| K181080 — McKesson Cardiology | Change Healthcare Israel , Ltd. May 24, 2018 |
| K180976 — PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation May 24, 2018 |
| K181108 — Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC May 24, 2018 |
| K180609 — Rodo Smilekey | Rodo Medical, Inc. May 23, 2018 |
| K181067 — AlignX Ankle Fusion System | Extremity Medical, LLC May 23, 2018 |
| K180201 — Route 92 Medical Access System | Route 92 Medical, Inc. May 23, 2018 |
| K180811 — Biograph Vision | Siemens Medical Solutions USA, Inc. May 23, 2018 |
| K181059 — geko T-3 Neuromuscular Stimulator | Firstkind Limited May 23, 2018 |
| K173722 — PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. May 23, 2018 |
| K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. May 23, 2018 |
| K180403 — ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length | Ethicon Endo-Surgery, LLC May 23, 2018 |
| K180808 — Omni Foot Plating System | Extremity Medical, LLC May 22, 2018 |
| K173405 — DiLumen Endolumenal Interventional Scissors (DiLumen Is) | Lumendi, LLC May 22, 2018 |
| K180455 — NeuralBot | Neural Analytics, Inc. May 22, 2018 |
| K180270 — Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies May 22, 2018 |
| K173862 — Pantheris System | Avinger, Inc. May 22, 2018 |
| K180773 — Reusable and Self-Adhesive Electrodes | Shaoxing Dongzhi Electrical Technology Co., Ltd. May 22, 2018 |
| K180662 — Arthrex FastThread Interference Screw | Arthrex, Inc. May 22, 2018 |
| K173956 — Biowy PlCC Catheter | Biowy Corporation May 21, 2018 |
| K173395 — MECALL CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A May 21, 2018 |
| K180197 — Erchonia FX-635 | Erchonia Corporation May 21, 2018 |
| K172729 — Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. May 21, 2018 |
| K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC May 21, 2018 |
| K180545 — VACUETTE SAFELINK Holder with male luer lock | Greiner Bio-One Na, Inc. May 21, 2018 |
| K180817 — AERIAL Interspinous Fixation | Globus Medical, Inc. May 21, 2018 |
| K180220 — SAGICO OSI Spinal System by Osimplant | Spinal Analytics & Geometrical Implant Co, LLC May 21, 2018 |
| K181145 — Eclipse Treatment Planning System | Varian Medical Systems, Inc. May 18, 2018 |
| K172209 — AURA ICP MONITORING SYSTEM | Branchpoint Technologies, Inc. May 18, 2018 |
| K180508 — JOULE SYSTEM | Sciton, Inc May 18, 2018 |
| K180087 — A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. May 18, 2018 |
| K180700 — KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. May 18, 2018 |
| K181179 — BrainScope One | Brainscope Company, Inc. May 18, 2018 |
| K173110 — GRAFTSITE | Summit Medical , Ltd. May 18, 2018 |