| K172087 — SANGRAY | Hitachi , Ltd. Oct 27, 2017 |
| DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody | Ventana Medical Systems Oct 27, 2017 |
| K172803 — Infinitt PACS 7.0 | Infinitt Healthcare Co., Ltd. Oct 27, 2017 |
| K172534 — LINACwatch, LinacView | Qualiformed Sarl Oct 27, 2017 |
| K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. Oct 27, 2017 |
| K173138 — Biim Diagnostic Ultrasound System | Biim Ultrasound AS Oct 27, 2017 |
| K172028 — Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company Oct 27, 2017 |
| K173094 — OrthoVision | Ewoosoft Co., Ltd. Oct 26, 2017 |
| K173046 — Cocoon Portable Handheld X-Ray System | Dexcowin Co., Ltd. Oct 26, 2017 |
| K171931 — Celerity ECG Cable Accessory Pack | Medcomp (Medical Components, Inc.) Oct 26, 2017 |
| K171831 — Intra-Lock Bone Fixation System | Intra-Lock International, Inc. Oct 26, 2017 |
| K172325 — Rhapsody H-30 Holmium Laser System | Cook Incorporated Oct 26, 2017 |
| K173022 — SeaSpine Ventura NanoMetalene System | SeaSpine Orthopedics Corporation Oct 26, 2017 |
| K172994 — EPI K Console | Moria SA Oct 26, 2017 |
| K172341 — NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated Oct 26, 2017 |
| K172323 — Omnia Medical VBR | Omnia Medical, LLC Oct 26, 2017 |
| K171142 — Healing Cap Multi-Unit Titanium | Nobel Biocare AB Oct 26, 2017 |
| K172417 — SILC® Fixation System | Globus Medical, Inc. Oct 26, 2017 |
| K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel | Advance Medical Designs, Inc. Oct 25, 2017 |
| K172334 — Ortus Expandable Lumbar Interbody Fusion System | Atlas Spine, Inc. Oct 25, 2017 |
| K172970 — M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 25, 2017 |
| K170307 — SunCHECK | Sun Nuclear Corporation Oct 25, 2017 |
| K172200 — 3880 MRI Patient Monitoring System | Iradimed Corporation Oct 25, 2017 |
| K170293 — Emit II Plus Cocaine Metabolite Assay | Siemens Healthcare Diagnostics, Inc. Oct 25, 2017 |
| K173242 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) | Aziyo Biologics, Inc. Oct 25, 2017 |
| K170423 — DentureID Microchip | Cmp Industries, LLC Oct 25, 2017 |
| K172600 — AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | Alcon Laboratories, Inc. Oct 25, 2017 |
| K171946 — Gel-Bead | Vascular Solutions, Inc. Oct 25, 2017 |
| K172808 — CosmoLock Pedicle Screw System | Kalitec Direct, LLC Oct 25, 2017 |
| K172132 — CleanCision Wound Retraction and Protection System | Prescient Surgical, Inc. Oct 25, 2017 |
| K173095 — VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations | Medos International SARL Oct 25, 2017 |
| K173031 — AtriClip LAA Exclusion System with Preloaded PRO·V Clip | AtriCure, Inc. Oct 25, 2017 |
| K162652 — Smart Photon Micro-current Device, Model: EP-300 | Li-Tek Electronic Technology Corporation Oct 25, 2017 |
| K170226 — iTotal Family Reusable Instrument Tray | Conformis, Inc. Oct 25, 2017 |
| K171914 — Cortina Lumbar Cage System | Neurostructures, Inc. Oct 25, 2017 |
| K170454 — Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U | Honsun (Nantong) Co., Ltd. Oct 25, 2017 |
| K172626 — Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir | Medtronic, Inc. Oct 25, 2017 |
| K172617 — Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. Oct 25, 2017 |
| K172455 — CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | Volcano Corporation Oct 25, 2017 |
| K172937 — Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC Oct 25, 2017 |
| K171751 — SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module | Capsule Technologie Sas Oct 24, 2017 |
| K172307 — Dynamic Coronary Roadmap 2.0 | Philips Medical Systems Nederland B.V. Oct 24, 2017 |
| K172000 — ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC Oct 24, 2017 |
| K172251 — UTS Stem | United Orthopedic Corporation Oct 24, 2017 |
| K170320 — Alinity c ICT Sample Diluent | Abbott Laboratories Oct 24, 2017 |
| K171575 — ENFLU 18 (enflufocon A) Daily Wear Contact Lens | Contamac, Ltd. Oct 24, 2017 |
| K172951 — Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Varex Imaging Corporation Oct 24, 2017 |
| K170612 — STERILE VINYL EXAMINATION GLOVES, Powder Free | Primus Gloves Pvt Limited Oct 23, 2017 |
| K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. Oct 23, 2017 |
| K172282 — Panther Fusion Paraflu Assay | Hologic, Inc. Oct 23, 2017 |