| K161521 — TAP Blood Collection Device | Seventh Sense Biosystems, Inc. Feb 16, 2017 |
| K162402 — 4CIS® Marlin ACIF Cage System | Solco Biomedical Co., Ltd. Feb 16, 2017 |
| K162365 — T-Cuff | Terumobct, Inc. Feb 16, 2017 |
| K162965 — SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Tei Biosciences, Inc. Feb 16, 2017 |
| K163416 — Fiagon Navigation PointerTube Straight and PointerTube Keat | Fiagon GmbH Feb 16, 2017 |
| DEN140033 — Companion | Lgch, Inc. Feb 16, 2017 |
| K162760 — Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. Feb 16, 2017 |
| K170160 — Abbott ARCHITECT Free T3 | Abbott Laboratories Feb 15, 2017 |
| K161811 — Medela Low Dose Enteral Syringe | Medela, Inc. Feb 15, 2017 |
| K160876 — PC ECG | Edan Instruments, Inc. Feb 15, 2017 |
| K162099 — IBS Implant System II | Innobiosurg Co., Ltd. Feb 15, 2017 |
| K170163 — Erisma® LP Spinal Fixation System | Clariance, Sas Feb 14, 2017 |
| K163460 — Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. Feb 14, 2017 |
| DEN160048 — FilmArray NGDS Warrior Panel | Biofire Defense, LLC Feb 14, 2017 |
| K162830 — SIS Software | Surgical Information Sciences, Inc. Feb 14, 2017 |
| K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC Feb 14, 2017 |
| K162608 — ClariFix Device | Arrinex, Inc. Feb 14, 2017 |
| K163548 — ENSEAL X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC Feb 14, 2017 |
| K162987 — FA100 SCCD (Sequential Continuous Contraction Device) | Flowaid Medical Technologies, Corp Feb 14, 2017 |
| K162590 — Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. Feb 14, 2017 |
| K163619 — SIGNA PET/MR | Ge Medical Systems, LLC Feb 14, 2017 |
| K163285 — syngo Application Software | Siemens Medical Solution USA, Inc. Feb 14, 2017 |
| K162668 — Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. Feb 14, 2017 |
| K160610 — Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set | Kobold, LLC Feb 13, 2017 |
| K162508 — KerraCel Ag Gelling Fiber Silver Dressing | Exciton Technologies, Inc. Feb 13, 2017 |
| K160918 — JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora Feb 13, 2017 |
| K163380 — Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC Feb 13, 2017 |
| K161510 — VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) | bioMerieux, Inc. Feb 13, 2017 |
| K170193 — Advance 14LP Low Profile PTA Balloon Dilatation Catheter | Cook Incorporated Feb 13, 2017 |
| K163487 — Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. Feb 13, 2017 |
| K162860 — MCS Bone Graft | Bioventus, LLC Feb 13, 2017 |
| K163146 — POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. Feb 13, 2017 |
| K162456 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid Feb 13, 2017 |
| K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | Medtronic, Inc. Feb 10, 2017 |
| K163395 — Astroglide Diamond Silicone Gel Personal Lubricant | Biofilm, Inc. Feb 10, 2017 |
| K163596 — LOGIQ P9 and LOGIQ P7 | GE Healthcare Feb 10, 2017 |
| K161226 — Revision Femoral Stem | Lima Corporate S.P.A. Feb 10, 2017 |
| K162089 — Blood Pressure Monitor | Beijing Choice Electronic Technology Co., Ltd. Feb 10, 2017 |
| K163217 — GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. Feb 10, 2017 |
| K161415 — SteriTite Containers System & MediTray Products | Case Medical, Inc. Feb 10, 2017 |
| K161213 — XSmart iQ | Dentsply Sirona Feb 10, 2017 |
| K162321 — EasyClip Xpress | Restore Surgical, LLC Dba Instratek Feb 10, 2017 |
| K162697 — Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal | Custom Orthopaedic Solutions, Inc. Feb 10, 2017 |
| K161629 — CRYLREX | Sm Eng Co., Ltd. Feb 10, 2017 |
| K161606 — Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | Terumo Europe N.V. Feb 10, 2017 |
| K162918 — Atlas Spine Expandable Interbody System | Atlas Spine, Inc. Feb 9, 2017 |
| K161413 — Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. Feb 9, 2017 |
| K170086 — Pinnacle Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. Feb 9, 2017 |
| K162710 — Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | Tgs Medical Co., Ltd. Feb 9, 2017 |
| K163508 — PIVO | Velano Vascular Feb 9, 2017 |