| K182677 — DynaNail Mini | MedShape, Inc. Feb 14, 2019 |
| K183506 — HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL Feb 14, 2019 |
| K183635 — PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. Feb 14, 2019 |
| K182756 — MyoStrain 5.1 | Myocardial Solutions Feb 14, 2019 |
| K183063 — Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. Feb 14, 2019 |
| K183083 — Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation Feb 14, 2019 |
| K181930 — GMC Wrist Automatic Blood Pressure Monitor | Gmc, Inc. Feb 14, 2019 |
| K183196 — Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | Stryker Corporation Feb 14, 2019 |
| K181315 — Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | Winner Medical Co., Ltd. Feb 14, 2019 |
| K181508 — U&U Blood Collection Sets | U&U Medical Technology Co, Ltd. Feb 13, 2019 |
| K182661 — Kava and Kava with Herbst | Sketchpad Innovations, LLC Feb 13, 2019 |
| K182974 — NuVasive Reline System | Nu Vasive, Incorporated Feb 13, 2019 |
| K182874 — Fenom Pro Nitric Oxide Test | Spirosure, Inc. Feb 13, 2019 |
| K182915 — ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. Feb 13, 2019 |
| K182991 — EPIC Extremity Fusion Plate System | Epic Extremity, LLC Feb 13, 2019 |
| K183161 — SnapShot Freeze 2 | Ge Medical Systems, LLC Feb 13, 2019 |
| K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. Feb 13, 2019 |
| K182934 — FORA P100 Blood Pressure Monitoring System | Taidoc Technology Corporation Feb 12, 2019 |
| K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) | Beckman Coulter, Inc. Feb 12, 2019 |
| K190075 — Aurora Evacuator | Rebound Therapeutics Feb 12, 2019 |
| K190056 — KOWA VK-2s | Kowa Co. Ltd. Chofu Feb 12, 2019 |
| K181955 — WiEMSpro | Medical Cables S.L. Feb 12, 2019 |
| K183167 — Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Incorporated Feb 12, 2019 |
| K183375 — Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. Feb 12, 2019 |
| K183637 — Cruxcan (CRX-1000) | Cruxell Corp. Feb 12, 2019 |
| K190085 — Journey II Unicompartmental Knee System | Smith & Nephew, Inc. Feb 11, 2019 |
| K183585 — Elitone Device | Elidah, Inc. Feb 11, 2019 |
| K183409 — Athena II Cervical Plate System | Medyssey USA, Inc. Feb 11, 2019 |
| K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. Feb 11, 2019 |
| K183396 — HANAROSTENT FASTTM Biliary (NNN) | M.I.Tech Co., Ltd. Feb 11, 2019 |
| K190078 — IntraSight | Volcano Corporation Feb 11, 2019 |
| K183073 — SMG Anterior Cervical Plate System | Sapphire Medical Group Feb 11, 2019 |
| K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | Titan Spine, Inc. Feb 11, 2019 |
| K180691 — TrueDorsal Devices | True Function Laboratory, Inc. Feb 11, 2019 |
| K183477 — easyPPHTM Hemorrhoidal Stapler for Single Use | Ezisurg Medical Co., Ltd. Feb 11, 2019 |
| K181340 — Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. Feb 11, 2019 |
| K181143 — Keeler TonoCare Tonometer | Keeler Instruments, Inc. Feb 8, 2019 |
| K180835 — SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. Feb 8, 2019 |
| K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. Feb 8, 2019 |
| K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | Oridion Medical 1987 , Ltd. Feb 8, 2019 |
| K183245 — Carestream DRX-1 System with DRX Plus 2530 Detectors | Carestream Health, Inc. Feb 8, 2019 |
| K183141 — LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG Feb 8, 2019 |
| K182040 — Coala Heart Monitor | Coala Life AB Feb 8, 2019 |
| K183186 — Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24 | Shanghai United Imaging Healthcare Co., Ltd. Feb 8, 2019 |
| K182833 — ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | The Argen Corporation Feb 8, 2019 |
| K183517 — Ammonia II | Roche Diagnostics Operations (Rdo) Feb 8, 2019 |
| K182417 — ROSA ONE Brain Application | Medtech S.A Feb 7, 2019 |
| K183134 — ArcTV Transvaginal Sling System | Urocure, LLC Feb 7, 2019 |
| K183235 — SonoSite SII Ultrasound System | FUJIFILM Sonosite, Inc. Feb 7, 2019 |
| K182224 — SafeAir Smoke Evacuator compact | Lina Medical Aps Feb 7, 2019 |