| DEN170070 — MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit | Cytocell, Ltd. Dec 21, 2018 |
| K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. Dec 21, 2018 |
| K162553 — AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare Dec 20, 2018 |
| K182165 — Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Shenzhen Well.D Medical Electronics Co., Ltd. Dec 20, 2018 |
| DEN170072 — Enlight 1810 | Timpel, Inc. Dec 20, 2018 |
| K183115 — MTS Levofloxacin 0.002 - 32 µg/mL | Liofilchem S.R.L. Dec 20, 2018 |
| K180828 — Natureplex Warm Touch Warming Jelly | Natureplex, LLC Dec 20, 2018 |
| K182320 — BD Contoured Base Pen Needle | Becton, Dickinson And Company Dec 20, 2018 |
| K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated Dec 20, 2018 |
| DEN170021 — SEM Scanner (Model 200) | Bruin Biometrics, LLC Dec 20, 2018 |
| K173041 — 3DIEMME RealGUIDE | 3Diemme , Ltd. Dec 20, 2018 |
| K181838 — Sinusway Dilation System | 3Nt Medical , Ltd. Dec 20, 2018 |
| K182972 — Phoenix Atherectomy System | Volcano Atheromed, Inc. Dec 20, 2018 |
| K181861 — Embrace | Empatica S.R.L. Dec 20, 2018 |
| K180830 — Reuter Tip Deflecting Wire Guide | Cook Incorporated Dec 20, 2018 |
| K182420 — ASAHI Corsair Pro XS | Asahi Intecc Co., Ltd. Dec 20, 2018 |
| K182454 — O2 Concepts Oxlife Independence Model 301-0001 | O2 Concepts, LLC Dec 20, 2018 |
| K182670 — FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | Prosidyan, Inc. Dec 20, 2018 |
| K183267 — DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. Dec 20, 2018 |
| K181589 — Curiteva Lumbar Interbody Fusion System | Curiteva, LLC Dec 20, 2018 |
| K183123 — microTargeting Guideline 4000 5.0 System | FHC, Inc. Dec 20, 2018 |
| K183036 — Dilator Sets | Cook Incorporated Dec 20, 2018 |
| K182149 — FFRangio System | Cathworks, Ltd. Dec 19, 2018 |
| K173140 — VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | Vivachek Laboratories, Inc. Dec 19, 2018 |
| K182116 — BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas Dec 19, 2018 |
| K180863 — FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation Dec 19, 2018 |
| K180846 — Arterial Pressure Monitoring Set/Tray | Cook Incorporated Dec 19, 2018 |
| K181785 — Modified BrainScope One | Brainscope Company, Inc. Dec 19, 2018 |
| K182190 — Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. Dec 19, 2018 |
| K183239 — CoreLink F3D Lateral System | Corelink, LLC Dec 19, 2018 |
| K182446 — TruShot with Y-Knot All-Suture Anchor | Conmed Corporation Dec 19, 2018 |
| K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC Dec 19, 2018 |
| K182610 — Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic Dec 19, 2018 |
| K182878 — Integra Salto Total Ankle System | Ascension Orthopedics Dec 18, 2018 |
| K181087 — Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. Dec 18, 2018 |
| K182422 — Lucitone Denture Base Materials | Dentsply Sirona Dec 18, 2018 |
| K182624 — MIM - MRT Dosimetry | Mim Software, Inc. Dec 18, 2018 |
| K182150 — Devon 52 Sequential Compression Device | Devon Medical Products (Jiangsu), Ltd. Dec 18, 2018 |
| K180909 — REVEL Spacers | Globus Medical, Inc. Dec 18, 2018 |
| K181756 — Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB Dec 18, 2018 |
| K182424 — NuFACE FIX Skin Toning Device | Carol Cole Company Dba Nuface Dec 18, 2018 |
| K182989 — AURORA Screw System | MiRus, LLC Dec 18, 2018 |
| K182938 — Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. Dec 18, 2018 |
| K182361 — Arthrex Compression FT Screws | Arthrex, Inc. Dec 18, 2018 |
| K182747 — EliA RF IgM Immunoassay | Phadia AB Dec 18, 2018 |
| K182595 — HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Dec 18, 2018 |
| K183253 — ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated Dec 18, 2018 |
| K182593 — KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. Dec 18, 2018 |
| K181496 — VINTAGE PRO | Shofu Dental Corporation Dec 18, 2018 |
| K183185 — Riptide Aspiration System (Riptide Large Bore Aspiration System) | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Dec 18, 2018 |