| K173355 — Gastric Sizing Balloon Catheter | Cook Incorporated Nov 17, 2017 |
| K172362 — DEKA SMARTXIDE TOUCH | El.En Electronic Engineering Spa Nov 17, 2017 |
| K171742 — N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | Siemens Healthcare Diagnostics Products GmbH Nov 17, 2017 |
| K170544 — Langston dual lumen catheter | Vascular Solutions, Inc. Nov 17, 2017 |
| K172223 — SleepRight ProRx Custom Dental Guard | Splintek, Inc. Nov 17, 2017 |
| K171270 — DIGITAL RADIOGRAPHY CXDI-410C WIRELESS | Canon, Inc. Nov 17, 2017 |
| K172878 — Vantage Titan 3T, MRT-3010/A7, M-Power GX | Toshiba Medical Systems Corporation, Japan Nov 17, 2017 |
| K172761 — New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) | Shanghai New Century Dental Materials Co., Ltd. Nov 17, 2017 |
| K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. Nov 16, 2017 |
| K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Nov 16, 2017 |
| K172856 — Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | Stryker Sustainability Solutions Nov 16, 2017 |
| K170517 — Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries (Suzhou) Co., Ltd. Nov 16, 2017 |
| K172535 — Bipolar applicator CELON ProCurve V | Olympus Winter & Ibe GmbH Nov 16, 2017 |
| K173314 — LessRay System | Nu Vasive, Incorporated Nov 16, 2017 |
| K171482 — NEPHROCHECK Test System | Astute Medical, Inc. Nov 16, 2017 |
| K173051 — Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | Orthofix Srl Nov 16, 2017 |
| K171543 — Renovis Surgical Hip Replacement System | Renovis Surgical Technologies Nov 16, 2017 |
| K171254 — LeEject 2 Dental Syringe and Needle System | Advanced Technology And Capital, Inc. Nov 16, 2017 |
| K163472 — Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. Nov 16, 2017 |
| K163643 — SIRIO H3 | Masmec Spa Nov 16, 2017 |
| K171618 — Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) Nov 16, 2017 |
| K171610 — MC3 QuickFlow Dual Lumen Catheter | Mc3 Incorporated Nov 16, 2017 |
| K170606 — Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab Nov 16, 2017 |
| K173319 — KaVo NOMAD Pro 2 Handheld X-ray System | Aribex Nov 16, 2017 |
| K170022 — Klockner Vega TiBase for CEREC | SOADCO, S.L. Nov 16, 2017 |
| K172178 — Minimally Invasive Bunion Plating System | Trilliant Surgical, Ltd. Nov 16, 2017 |
| K172130 — Resorbable Mesh Device | SeaSpine Orthopedics Corporation Nov 16, 2017 |
| K171816 — Kardia Band System | AliveCor, Inc. Nov 16, 2017 |
| K173331 — JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. Nov 16, 2017 |
| K173284 — OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) | Boston Scientific Corporation Nov 16, 2017 |
| K172550 — OEC Elite | Ge Oec Medical Systems, Inc. Nov 16, 2017 |
| K173187 — MobileDiagnost M50 | Philips India Limited Nov 16, 2017 |
| K172849 — Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | Intellijoint Surgical, Inc. Nov 16, 2017 |
| K170362 — VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | Coloplast Corp. Nov 15, 2017 |
| K171886 — OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. Nov 15, 2017 |
| DEN170018 — NSS-2 System | Innovative Health Solutions (Ihs), Inc. Nov 15, 2017 |
| K173016 — Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color | Anhui Kindguard Medical Supplies Technology Co., Ltd. Nov 15, 2017 |
| K171873 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | Zhonghong Pulin Medical Products Co., Ltd. Nov 15, 2017 |
| K173329 — jFit Surgical Planner | Jointvue, LLC Nov 15, 2017 |
| DEN170058 — MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay | Memorial Sloan-Kettering Cancer Center Nov 15, 2017 |
| K171901 — uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 15, 2017 |
| K171736 — Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. Nov 15, 2017 |
| K173003 — U50 Diagnostic Ultrasound System | Edan Instruments, Inc. Nov 15, 2017 |
| K173289 — Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | Cook Incorporated Nov 15, 2017 |
| K172851 — Microcyn Plus Antimicrobial Wound Care Solution | Sonoma Pharmaceuticals, Inc. Nov 15, 2017 |
| K171815 — Registrado Scan | Voco GmbH Nov 15, 2017 |
| K170206 — Arthrex FiberTape Cerclage | Arthrex, Inc. Nov 15, 2017 |
| K173410 — n!ce for Planmill | Institut Straumann AG Nov 14, 2017 |
| K172157 — DePuy Synthes Femoral Recon Nail System | Synthes (USA) Products, LLC Nov 14, 2017 |
| K171769 — Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf Of Institut Straumann Ag) Nov 14, 2017 |