| K171473 — Compressyn Staple | Dallen Medical, Inc. Nov 7, 2017 |
| K163694 — Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs , Ltd. Nov 7, 2017 |
| K172392 — Lateral Spinal Truss System (LSTS) Interbody Fusion Device | 4Web, Inc. Nov 7, 2017 |
| K172446 — SPIRA-C Open Matrix Cervical Interbody | Camber Spine Technologies Nov 7, 2017 |
| K170464 — StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation Nov 7, 2017 |
| K172177 — Insulia Diabetes Management Companion | Voluntis Sa. Nov 7, 2017 |
| K171365 — Arthrex Knee Systems | Arthrex, Inc. Nov 7, 2017 |
| K173265 — UltraVision 2 Diagnostic Ultrasound System | Winprobe Corporation Nov 7, 2017 |
| K173086 — NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. Nov 7, 2017 |
| K163634 — External Hex Implants | Southern Implants (Pty), Ltd. Nov 6, 2017 |
| K172442 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Hartalega NGC Sdn. Bhd. Nov 6, 2017 |
| K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. Nov 6, 2017 |
| K172712 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | Gri Medical & Electronic Technology Co., Ltd. Nov 6, 2017 |
| K172979 — NuVasive® Growth Rod Conversion Set | Nu Vasive, Incorporated Nov 6, 2017 |
| K172441 — EPIC Extremity Fracture Plate System | Epic Extremity, LLC Nov 6, 2017 |
| K172260 — Omni Foot Plating System | Extremity Medical, LLC Nov 6, 2017 |
| K172060 — Capio SLIM Suture Capturing Device | Boston Scientific Corporation Nov 3, 2017 |
| K172277 — Phlebo Press DVT Model | Mego Afek AC , Ltd. Nov 3, 2017 |
| K172711 — Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Nov 3, 2017 |
| K172591 — Fixed Patient Leads ECG Cable (Model 3153) | Boston Scientific Corporation Nov 3, 2017 |
| K171788 — Reprocessed Halo XP Diagnostic Electrophysiology Catheter | Innovative Health, LLC Nov 3, 2017 |
| K170965 — Fingertip Pulse Oximeter | Shenzhen Jumper Medical Equipment Co., Ltd. Nov 3, 2017 |
| K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | Stimwave Technologies Incorporated Nov 3, 2017 |
| K172639 — PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. Nov 3, 2017 |
| K172054 — Materialise Glenoid Positioning System | Materialise NV Nov 3, 2017 |
| K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Datex-Ohmeda, Inc. Nov 3, 2017 |
| K172609 — CSMC Cardiac Suite | Cedars-Sinai Medical Center Nov 3, 2017 |
| K171842 — Geistlich Wound Matrix | Geistlich Pharma AG Nov 3, 2017 |
| K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site | B.Braun Medical, Inc. Nov 3, 2017 |
| K163087 — PixoTest Blood Glucose Monitoring System | Ixensor Company , Ltd. Nov 2, 2017 |
| K170080 — Neodent Implant System - CM Pro PEEK Abutment | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Nov 2, 2017 |
| K163223 — ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC Nov 2, 2017 |
| K170422 — BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | Coloplast Corp. Nov 2, 2017 |
| K172674 — Sapphire Cervical Implant System | Sapphire Medical Group Nov 2, 2017 |
| K172757 — Valleylab FX8 Electrosurgical Platform | Covidien, LLC Nov 2, 2017 |
| K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator | Terragene S.A. Nov 2, 2017 |
| K173341 — Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Nov 2, 2017 |
| K172407 — Duracetal | The Myerson Company Limited Nov 2, 2017 |
| K163453 — VitalPatch® VitalConnect Platform | Vitalconnect, Inc. Nov 2, 2017 |
| K172328 — SOVEREIGN Spinal System | Medtronic Sofamor Danek USA, Inc. Nov 2, 2017 |
| K171376 — DynaNail TTC Fusion System | MedShape, Inc. Nov 2, 2017 |
| K172437 — CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System | Orthofix, Inc. Nov 2, 2017 |
| K173232 — myMerlin(TM) Mobile Application Model APP1001 | St Jude Medical Nov 2, 2017 |
| K172301 — Mako Partial Knee Application | Mako Surgical Corp. Nov 2, 2017 |
| K170405 — BD Curve Ascites Shunt | Care Fusion Nov 2, 2017 |
| K170853 — InnoSpire Go | Respironics Respiratory Drug Delivery (Uk) , Ltd. Nov 2, 2017 |
| K170341 — Medussa-PL Cage | Medyssey USA, Inc. Nov 2, 2017 |
| K172373 — Compound W Nitro-Freeze | Medtech Products, Inc. Nov 2, 2017 |
| K171370 — IMAGEnet 6 Ophthalmic Data System | Topcon Corporation Nov 1, 2017 |
| K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. Nov 1, 2017 |