| K172380 — U2 Diagnostic Ultrasound System | Edan Instruments, Inc. Sep 29, 2017 |
| K172065 — SCARLET AC-T | Spineart Sep 29, 2017 |
| K171440 — Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi Sep 29, 2017 |
| K172631 — Arisure Dry Spike | Yukon Medical Sep 29, 2017 |
| K171795 — Thommen Implant System | Thommen Medical AG Sep 29, 2017 |
| K171463 — ASPIRE Bellus II | Fujifilm Medical Systems U.S.A, Inc. Sep 29, 2017 |
| K171309 — BR-FHUS Navigation 1.0 | Taihao Medical, Inc. Sep 29, 2017 |
| K172342 — Voluson E6, Voluson E8, Voluson E10 | GE Healthcare Sep 29, 2017 |
| K172309 — Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. Sep 29, 2017 |
| K171685 — Med4 Elite | Cool Systems, Inc. (Dba Game Ready) Sep 29, 2017 |
| K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. Sep 29, 2017 |
| K172397 — Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. Sep 29, 2017 |
| K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | Genea Biomedx Pty, Ltd. Sep 28, 2017 |
| K172659 — MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture | M/S. Meril Endo Surgery Private Limited. Sep 28, 2017 |
| K170262 — Digital Thermometer | K-Jump Health Co., Ltd. Sep 28, 2017 |
| K171894 — NuVasive® Precept Spinal System | Nu Vasive, Incorporated Sep 28, 2017 |
| K171212 — AirFit N20 | Resmed, Ltd. Sep 28, 2017 |
| K163455 — SurgiCube | Surgicube International B.V. Sep 28, 2017 |
| K172595 — CUSA Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation Sep 28, 2017 |
| K170020 — Peel-Away Introducer Set | Cook Incorporated Sep 28, 2017 |
| K170802 — TRAUMACEM V+ Injectable Bone Cement | Synthes (USA) Products, LLC Sep 28, 2017 |
| K171633 — NuVasive TLX Interbody System | Nu Vasive, Incorporated Sep 28, 2017 |
| K171965 — Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH Sep 28, 2017 |
| K163442 — Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) | Modern Medical Equipment Manufacturing Limited Sep 28, 2017 |
| K171922 — Anatotemp Anatomic Dental Implant Healing Abutment | Buckeye Medical Technologies, LLC Sep 28, 2017 |
| K172612 — FiberTak DX | Arthex, Inc. Sep 28, 2017 |
| K171728 — MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | Sterngold Dental, LLC Sep 28, 2017 |
| K161434 — Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) | Li-Tek Electronics Technologies Sep 28, 2017 |
| K172109 — Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL | Liofilchem S.R.L. Sep 27, 2017 |
| K171936 — Peerbridge Cor(TM) System | Peerbridge Health, Inc. Sep 27, 2017 |
| K172275 — Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | Zimmer Biomet Spine, Inc. Sep 27, 2017 |
| K171211 — OIC External Fixation System | Orthopaedic Implant Company Sep 27, 2017 |
| K171661 — Scopis Extended Instrument Set EM | Scopis GmbH Sep 27, 2017 |
| K170183 — Cetus system, Cetus probe | A.R.C Laser GmbH Sep 27, 2017 |
| K170482 — Spider Frame External Fixation System | Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S Sep 27, 2017 |
| K171215 — QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. Sep 27, 2017 |
| K170810 — CRYOFOS | Cryofos Medical GmbH Sep 27, 2017 |
| K171941 — FreeStyle Precision Neo Blood Glucose Test Strips | Abbott Diabetes Care, Inc. Sep 27, 2017 |
| K172101 — ROMEO® 2 Posterior Osteosynthesis System | Spineart Sep 26, 2017 |
| K170816 — Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM | Brainlab AG Sep 26, 2017 |
| K170162 — Vesco Medical Nasoenteric Feeding Tubes | Vesco Medical, LLC Sep 26, 2017 |
| K171963 — Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes | Hologic, Inc. Sep 26, 2017 |
| K172015 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | Careglove Global Sdn. Bhd. Sep 26, 2017 |
| K171107 — CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | Medtronic Sofamor Danek USA, Inc. Sep 26, 2017 |
| K172581 — CareView 1800Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. Sep 26, 2017 |
| K171992 — SculpSure | Cynosure, Inc. Sep 26, 2017 |
| K171442 — Exofin Fusion Skin Closure System | Chemence Medical, Inc. Sep 25, 2017 |
| K171161 — Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC Sep 25, 2017 |
| K171862 — GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. Sep 25, 2017 |
| K163577 — Ecofit® Hip System | Implantcast GmbH Sep 25, 2017 |