| K173131 — Rexious Spinal Fixation System | Huvexel Co. , Ltd. Dec 8, 2017 |
| K172731 — VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | bioMerieux, Inc. Dec 8, 2017 |
| K170818 — Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC Dec 7, 2017 |
| K171513 — Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps Dec 7, 2017 |
| K172578 — Equipment Pouch | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Dec 7, 2017 |
| K172270 — gammaCore-2 | Eletrocore, LLC Dec 7, 2017 |
| K171198 — NeuViz 16 Essence Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. Dec 7, 2017 |
| K173000 — Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | Shantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Dec 7, 2017 |
| K170720 — Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. Dec 7, 2017 |
| K172734 — Single Use Electrosurgical Snare SD-400 | Olympus Medical Systems Corp. Dec 7, 2017 |
| K170046 — Lilium a-200E | Lilium Otsuka Co., Ltd. Dec 7, 2017 |
| K173117 — NuVasive® VersaTie System | Nuvasive, Inc. Dec 7, 2017 |
| K171336 — Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | Henke-Sass, Wolf GmbH Dec 7, 2017 |
| K172908 — Q-Switched Nd:YAG Laser System | Ami, Inc. Dec 7, 2017 |
| K172010 — gel-e Bandage | Gel-E, Inc. (Formerly Remedium Technologies, Inc.) Dec 7, 2017 |
| K172912 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL) | Beckman Coulter, Inc. Dec 7, 2017 |
| K173267 — MasterLoc Stem: Lateralized Plus | Medacta International S.A. Dec 7, 2017 |
| K173458 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | Orthofix Srl Dec 7, 2017 |
| K172468 — 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | Inneuroco, Inc. Dec 6, 2017 |
| K173091 — Boundary Anterior Lumbar Buttress Plate | Nvision Biomedical Technologies, LLC Dec 6, 2017 |
| K172530 — BEAUTIFIL Flow Plus X | Shofu Dental Corporation Dec 6, 2017 |
| K173153 — Vertera Spine Coalesce Thoracolumbar Interbody Fusion System | Nu Vasive, Incorporated Dec 6, 2017 |
| K170797 — wettrust D2care | Wettrust Korea Co., Ltd. Dec 6, 2017 |
| K172425 — OrthoPediatrics Wrist Fusion Plate | Orthopediatrics, Inc. Dec 6, 2017 |
| K170934 — C3 Wave System | Medical Components, Inc (Dba Medcomp_ Dec 6, 2017 |
| K172707 — Renamel Microfill | Cosmedent, Inc. Dec 5, 2017 |
| K172618 — SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 | Olympus Medical Systems Corp. Dec 5, 2017 |
| K173126 — Arisstos Spinal System | Ingenium Spine Dec 5, 2017 |
| K172993 — P20 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. Dec 5, 2017 |
| K172561 — Disposable Circular Stapler | Changzhou Kangdi Medical Stapler Co., Ltd. Dec 5, 2017 |
| K172529 — Vivaer ARC Stylus | Aerin Medical, Inc. Dec 5, 2017 |
| K171447 — OxyPure Color Silicone Hydrogel Soft Contact Lenses | Visco Vision, Inc. Dec 5, 2017 |
| K172876 — PowerDot PD-01M | Smartmissimo Technologies Pte, Ltd. Dec 4, 2017 |
| K172629 — Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. Dec 4, 2017 |
| K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. Dec 4, 2017 |
| K173470 — ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath | Inari Medical Dec 4, 2017 |
| K172419 — Velofix TLIF Cage | U&I Corporation Dec 4, 2017 |
| K172085 — PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. Dec 4, 2017 |
| K173260 — SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System | SeaSpine Orthopedics Corporation Dec 4, 2017 |
| K171771 — ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. Dec 4, 2017 |
| K172931 — DUS-6000 Digital Ultrasonic Diagnostic Imaging System | Advanced Instrumentations, Inc. Dec 1, 2017 |
| K173266 — Octane aspiration system | Vascular Solutions, Inc. Dec 1, 2017 |
| K173038 — CuRAS Nd:YAG Laser | Ilooda Co,., Ltd. Dec 1, 2017 |
| K171773 — Straumann n!ce Glass Ceramic A14 Blocks | Institut Straumann AG Dec 1, 2017 |
| K173209 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL | Thermo Fisher Scientific Dec 1, 2017 |
| K171935 — Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. Dec 1, 2017 |
| K173058 — P10 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. Dec 1, 2017 |
| K171185 — IR Type Implant System | Biotem Co., Ltd. Dec 1, 2017 |
| K171352 — EZFluence | Radformation, Inc. Dec 1, 2017 |
| K172819 — LightWalker Laser System Family | Fotona D.O.O. Dec 1, 2017 |