| K163211 — MAGNETOM Sempra with syngo MR E11S | Siemens Medical Solutions USA, Inc. Jan 27, 2017 |
| K161767 — Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH Jan 27, 2017 |
| K162407 — L300 Go System | Bioness, Inc. Jan 27, 2017 |
| K161688 — Advanced Gynecological Applicator | Nucletron B.V. Jan 27, 2017 |
| K163312 — MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software | Siemens Medical Solutions USA, Inc. Jan 27, 2017 |
| K162427 — Vado Bi-Directional Steerable Sheath | Kalila Medical, Inc. Jan 27, 2017 |
| K163042 — chromID Strepto B agar | bioMerieux, Inc. Jan 27, 2017 |
| K162909 — CSX-30 Flat Panel Detector | Canon, Inc. Medical Equipment Group Jan 27, 2017 |
| K161236 — Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated Jan 27, 2017 |
| K162285 — EBM iDO Viewer 1.2.1 | Ebm Technologies Incorporated Jan 27, 2017 |
| K163281 — FastStroke | Gef Medical Systems Scs Jan 26, 2017 |
| K162587 — ROCCIA® ACIF | Silony Medical GmbH Jan 26, 2017 |
| K163179 — Onli Intermittent Catheter | Hollister Incorporated Jan 26, 2017 |
| K163574 — Multi Modality Viewer | Vital Images, Inc. Jan 26, 2017 |
| K163368 — FITBONE TAA | Wittenstein Intens GmbH Jan 26, 2017 |
| K163044 — ORTHOLOC® 3Di Ankle Fracture Plating System | Wrightmedicaltechnologyinc Jan 26, 2017 |
| K163660 — Pantera LEO | Biotronik, Inc. Jan 26, 2017 |
| K162790 — V.A.C.ULTA Negative Pressure Wound Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) Jan 26, 2017 |
| K161303 — dynaMX Compression Plate | Mx Orthopedics, Corp. Jan 26, 2017 |
| K161219 — Zmaxx T Series | Maxx Digm, Inc. Jan 26, 2017 |
| K162882 — KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. Jan 26, 2017 |
| K163693 — IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC Jan 26, 2017 |
| K163715 — Allura Xper R9 | Philips Medical Systems Nederland B.V. Jan 26, 2017 |
| K162226 — Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. Jan 25, 2017 |
| K160976 — Altus Spine Interbody Fusion System | Altus Partners, LLC Jan 25, 2017 |
| K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | Biomet, Inc. Jan 25, 2017 |
| K162786 — PASS LP Spinal System | Medicrea International SA Jan 25, 2017 |
| K162988 — PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. Jan 25, 2017 |
| K163258 — CrossFT Knotless Suture Anchor with Disposable Driver | Conmed Corporation Jan 25, 2017 |
| K162924 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) | Hartalega Sdb. Bhd. Jan 24, 2017 |
| K161466 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | Orthofix Srl Jan 24, 2017 |
| K163006 — VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) | bioMerieux, Inc. Jan 24, 2017 |
| K163705 — EzRay Air W | VATECH Co., Ltd. Jan 24, 2017 |
| K163014 — AOS Small Bone Nailing System | Advanced Orthopaedic Solutions, Inc. (Aos) Jan 24, 2017 |
| K170074 — nvc | Nvision Biomedical Technologies, LLC Jan 24, 2017 |
| K161686 — F&P InfoSmart | Fisher & Paykel Healthcare, Ltd. Jan 24, 2017 |
| K162802 — Barrx Anorectal RFA Wand | Covidien, LLC Jan 24, 2017 |
| K162851 — eLyx-PRO | Intelligent Sensory Concept SA Jan 24, 2017 |
| K162618 — CONCORD Plus Radiopaque Bone Cement | Globus Medical, Inc. Jan 23, 2017 |
| K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited Jan 23, 2017 |
| K162962 — OrthAlign Plus System | Orthalign, Inc. Jan 23, 2017 |
| K161231 — Facilis Spinal System | Baui Biotech Co., Ltd. Jan 23, 2017 |
| K160591 — D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV Jan 23, 2017 |
| K161823 — Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | Wrp Asia Pacific Sdn. Bhd. Jan 23, 2017 |
| K162606 — Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics Jan 23, 2017 |
| K163107 — Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC Jan 23, 2017 |
| K161178 — da Vinci Xi Surgical System | Intuitive Surgical, Inc. Jan 19, 2017 |
| K162472 — TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. Jan 19, 2017 |
| K162137 — Fever Scout Continuous Monitoring thermometer | VivaLNK, Inc. Jan 19, 2017 |
| K162242 — Comfort Flo Humidification System | Teleflexmedical, Inc. Jan 19, 2017 |