| K183400 — EnVisio Navigation Sytem | Elucent Medical, Inc. Mar 22, 2019 |
| K182700 — Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc Mar 22, 2019 |
| K181624 — Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | Oridion Medical 1987 , Ltd. Mar 22, 2019 |
| K182848 — ROSA ONE Spine application | Medtech S.A Mar 22, 2019 |
| K181738 — Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors | Surgical Instrument Service And Savings Inc (Dba Medline Mar 22, 2019 |
| K183608 — Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | Scientia Vascular, LLC Mar 22, 2019 |
| K183047 — Nalu Neurostimulation System | Boston Scientific Neuromodulation Mar 22, 2019 |
| K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | Steris Corporations Mar 22, 2019 |
| K183592 — ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | Beckman Coulter Mar 21, 2019 |
| K181822 — RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited Mar 21, 2019 |
| K182064 — ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. Mar 21, 2019 |
| K190377 — UroLift System UL400 | Neotract, Inc. Mar 21, 2019 |
| K182918 — Ballast 088 Long Sheath | Balt USA, LLC Mar 21, 2019 |
| K190431 — Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. Mar 21, 2019 |
| K190380 — nvc | Nvision Biomedical Technologies, Inc. Mar 21, 2019 |
| K190425 — CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. Mar 21, 2019 |
| K173191 — A&D Medical Blood Pressure Monitors | A&D Company, Ltd. Mar 21, 2019 |
| K182074 — Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. Mar 21, 2019 |
| K183582 — MPACT Extension | Medacta International S.A. Mar 21, 2019 |
| K190418 — NuVasive® VersaTie® System | Nu Vasive, Incorporated Mar 21, 2019 |
| K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. Mar 21, 2019 |
| K183414 — ABSOLU | Quantel Medical Mar 20, 2019 |
| K183399 — BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. Mar 20, 2019 |
| K183575 — ACUSON S3000, S2000 Diagnostic Ultrasound System | Siemens Healthineers Mar 20, 2019 |
| K182511 — SimplCath | F&S Medical Solutions, LLC Mar 20, 2019 |
| K183408 — Jensen Shade Effect Liquids | Jensen Industries, Inc. Mar 20, 2019 |
| K183543 — ACTIV.A.C. Therapy Unit | Kci USA, Inc. Mar 20, 2019 |
| K190423 — Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System | Devon Medical Products (Jiangsu), Ltd. Mar 19, 2019 |
| K183019 — SIS Software version 3.3.0 | Surgical Information Sciences, Inc. Mar 19, 2019 |
| K182383 — Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | Yty Industry (Manjung) Sdn Bhd Mar 19, 2019 |
| K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB Mar 19, 2019 |
| K182793 — AP3600 Automated Instrument | Hitachi Chemical Diagnostics, Inc. Mar 19, 2019 |
| K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Mar 19, 2019 |
| K183527 — MTS Ciprofloxacin 0.002 - 32 µg/mL | Liofilchem S.R.L. Mar 19, 2019 |
| K183529 — AE-120A EEG Head Set | Nihon Kohden Corporation Mar 19, 2019 |
| K190379 — MIM on Linux | Mim Software, Inc. Mar 19, 2019 |
| K183518 — Preat Abutments | Preat Corporation Mar 18, 2019 |
| K183344 — The Progressive Orthopaedic Company Total Knee System II | The Progressive Orthopaedic Company, LLC Mar 18, 2019 |
| K190366 — BRAUN Silk Expert Pro 3 | Cyden Limited Mar 18, 2019 |
| K190361 — Zavation Spinal System | Zavation Medical Products, LLC Mar 18, 2019 |
| K183260 — Sensilight Pro / Pistol IPL | El Global Trade, Ltd. Mar 18, 2019 |
| K190354 — BRAUN Silk.expert Pro 5 | Cyden Limited Mar 18, 2019 |
| K190333 — Paradigm All-Suture Anchor 1.8mm, White/Black #2 | Conmed Corporation Mar 18, 2019 |
| K183296 — REAL Immersive System | Penumbra, Inc. Mar 18, 2019 |
| K181599 — Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter Mar 18, 2019 |
| K190204 — ID NOW Influenza A & B 2 | Alere Scarborough, Inc. Mar 18, 2019 |
| K183511 — Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) | Medtronic, Inc. Mar 18, 2019 |
| K190359 — Sonendo GentleWave System | Sonendo, Inc. Mar 16, 2019 |
| K183187 — nextaro Transfer System, nextaro va | Sfm Medical Devices GmbH Mar 15, 2019 |
| K182813 — COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | Cotton High Tech S.L. Mar 15, 2019 |