| K180964 — Endoscope Sterilization Tray | Intuitive Surgical, Inc. Sep 28, 2018 |
| K181476 — Prime&Bond active Universal Adhesive | Dentsply Sirona Sep 28, 2018 |
| K181794 — Truliant Porous Femoral Components | Exactech, Inc. Sep 28, 2018 |
| K181124 — Acessa ProVu System | Acessa Health, Inc. Sep 28, 2018 |
| K181088 — TSP Crosser Transseptal Access System | Transseptal Solutions , Ltd. Sep 28, 2018 |
| K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. Sep 28, 2018 |
| K180241 — Orthocaps Twinaligner | Ortho Caps GmbH Sep 28, 2018 |
| DEN170080 — Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation Sep 28, 2018 |
| K181652 — Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | ETHICON, Inc. Sep 28, 2018 |
| K180041 — BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. Sep 28, 2018 |
| K173872 — FibriCheck | Qompium NV Sep 28, 2018 |
| K181771 — RightEye Vision System | Righteye, LLC Sep 28, 2018 |
| K180973 — Libertas Hip Replacement System | Maxx Orthopedics, Inc. Sep 28, 2018 |
| K181746 — MICRORAPTOR Knotless Suture Anchor | Smith And Nephew, Inc. Sep 28, 2018 |
| K180998 — BioHorizons CAD/CAM Bars | BioHorizons Implant Systems, Inc. Sep 28, 2018 |
| K180216 — Seidmon Antegrade AQ Stent Set | Cook Incorporated Sep 28, 2018 |
| K182415 — Alphenix, INFX-8000F/B, V8.0 | Canon Medical Systems Corporation Sep 28, 2018 |
| K181277 — E-CUBE 12 | Alpinion Medical Systems Co., Ltd. Sep 28, 2018 |
| K181608 — Disposable Standard Clamp | Standard Bariatrics Sep 27, 2018 |
| K182370 — Acculoc Total Knee System | Rootloc Co., Ltd. Sep 27, 2018 |
| K181021 — EmboCube Embolization Gelatin | Biosphere Medical, S.A. Sep 27, 2018 |
| K182402 — CoLink View Plating System | In2Bones USA, LLC Sep 27, 2018 |
| K181397 — DualX | Innovasive, Inc. Sep 27, 2018 |
| K181742 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH Sep 27, 2018 |
| K173833 — CRP Vario | SENTINEL CH. SpA Sep 27, 2018 |
| K181075 — PureSet Tray | Nobel Biocare AB Sep 27, 2018 |
| K182377 — CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. Sep 27, 2018 |
| K181975 — Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 | Oxoid Limited (Part Of Thermo Fisher Scientific) Sep 27, 2018 |
| K181991 — NxStage Connected Health System | Nxstage Medical, Inc. Sep 26, 2018 |
| K182315 — Magic Torque DLVR Guidewire | Boston Scientific Corporation Sep 26, 2018 |
| K182357 — HardyDisk AST Eravacycline 20µg (ERV20) | Hardy Diagnostics Sep 26, 2018 |
| K180803 — BeautiBond Universal | Shofu Dental Corporation Sep 26, 2018 |
| K181707 — Everyway Wireless TENS & EMS Unit | Everyway Medical Instruments Co.,Ltd Sep 26, 2018 |
| K182325 — InMode RF System | Inmode MD , Ltd. Sep 26, 2018 |
| K181066 — Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims | Eco Medi Glove Sdn. Bhd. Sep 26, 2018 |
| K181563 — The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | Access Scientific, LLC Sep 26, 2018 |
| K180340 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Sep 26, 2018 |
| K181591 — Fixated Asfora BULLET CAGE® (FABC) | Medical Designs, LLC Sep 26, 2018 |
| K181692 — 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) | Health Beacons, Inc. Sep 25, 2018 |
| K182335 — CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC Sep 25, 2018 |
| K181424 — PeDIA | Pedia, LLC Sep 25, 2018 |
| K182290 — IBM iConnect Access | Merge Healthcare Incorporated Sep 25, 2018 |
| K181904 — 5 FR Dual Lumen Piper PICC | Piper Access, LLC Sep 25, 2018 |
| K181773 — Synapse 3D Optional Tools | Fujifilm Corporation Sep 25, 2018 |
| K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B Sep 25, 2018 |
| K181795 — AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. Sep 25, 2018 |
| K181980 — OsseoScrew System | Alphatec Spine, Inc. Sep 25, 2018 |
| K182317 — AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH Sep 24, 2018 |
| K181611 — Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp Sep 24, 2018 |
| K181366 — REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. Sep 24, 2018 |