| Nexstim Navigated Brain Therapy (NBT) System 2 (K182700) | Nexstim Plc | 2019-03-22 |
| ELMED Laparoscopic Instruments and Accessories (K181173) | Elmed Incorporated | 2019-03-22 |
| ON-Q* Pump with Bolus (K181360) | Halyard Health | 2019-03-22 |
| CMOS Video-Rhino-Laryngoscope System (K182186) | KARL STORZ Endoscopy-America, Inc. | 2019-03-22 |
| Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (K182948) | Ansell Healthcare Products, LLC | 2019-03-22 |
| Masimo Rad-67 Pulse CO-Oximeter and Accessories (K182887) | Masimo Corporation | 2019-03-22 |
| HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) (K181959) | Owens & Minor Halyard, Inc. | 2019-03-22 |
| uWS-MR (K183164) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-03-22 |
| MPACT Extension (K183582) | Medacta International S.A. | 2019-03-21 |
| NuVasive® VersaTie® System (K190418) | Nu Vasive, Incorporated | 2019-03-21 |
| Ballast 088 Long Sheath (K182918) | Balt USA, LLC | 2019-03-21 |
| UroLift System UL400 (K190377) | Neotract, Inc. | 2019-03-21 |
| RENASYS Touch; RENASYS Y-Connector (K181822) | Smith & Nephew Medical Limited | 2019-03-21 |
| ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (K183592) | Beckman Coulter | 2019-03-21 |
| nvc (K190380) | Nvision Biomedical Technologies, Inc. | 2019-03-21 |
| Route 92 Medical Delivery Catheter (K190431) | Route 92 Medical, Inc. | 2019-03-21 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K190412) | Hangzhou Clongene Biotech Co., Ltd. | 2019-03-21 |
| CastleLoc-P Anterior Cervical Plate System (K190425) | L&K BIOMED Co., Ltd. | 2019-03-21 |
| A&D Medical Blood Pressure Monitors (K173191) | A&D Company, Ltd. | 2019-03-21 |
| ExpanSure Transseptal Dilation System (K182064) | Baylis Medical Company, Inc. | 2019-03-21 |
| Mineral Collagen Composite Bioactive Moldable (K182074) | Collagen Matrix, Inc. | 2019-03-21 |
| ABSOLU (K183414) | Quantel Medical | 2019-03-20 |
| BD Nexiva Closed IV Catheter System (K183399) | Becton Dickinson Infusion Therapy Systems, Inc. | 2019-03-20 |
| SimplCath (K182511) | F&S Medical Solutions, LLC | 2019-03-20 |
| ACUSON S3000, S2000 Diagnostic Ultrasound System (K183575) | Siemens Healthineers | 2019-03-20 |
| Jensen Shade Effect Liquids (K183408) | Jensen Industries, Inc. | 2019-03-20 |
| ACTIV.A.C. Therapy Unit (K183543) | Kci USA, Inc. | 2019-03-20 |
| Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System (K190423) | Devon Medical Products (Jiangsu), Ltd. | 2019-03-19 |
| SIS Software version 3.3.0 (K183019) | Surgical Information Sciences, Inc. | 2019-03-19 |
| Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (K182468) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019-03-19 |
| AP3600 Automated Instrument (K182793) | Hitachi Chemical Diagnostics, Inc. | 2019-03-19 |
| MTS Ciprofloxacin 0.002 - 32 µg/mL (K183527) | Liofilchem s.r.l. | 2019-03-19 |
| Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue (K182383) | Yty Industry (Manjung) Sdn Bhd | 2019-03-19 |
| AE-120A EEG Head Set (K183529) | Nihon Kohden Corporation | 2019-03-19 |
| SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (K180098) | Maquet Critical Care AB | 2019-03-19 |
| MIM on Linux (K190379) | Mim Software, Inc. | 2019-03-19 |
| BRAUN Silk Expert Pro 3 (K190366) | Cyden Limited | 2019-03-18 |
| 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) (K183511) | Medtronic, Inc. | 2019-03-18 |
| Preat Abutments (K183518) | Preat Corporation | 2019-03-18 |
| Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (K181599) | Beckman Coulter | 2019-03-18 |
| REAL Immersive System (K183296) | Penumbra, Inc. | 2019-03-18 |
| Zavation Spinal System (K190361) | Zavation Medical Products, LLC | 2019-03-18 |
| ID NOW Influenza A & B 2 (K190204) | Alere Scarborough, Inc. | 2019-03-18 |
| Paradigm All-Suture Anchor 1.8mm, White/Black #2 (K190333) | Conmed Corporation | 2019-03-18 |
| BRAUN Silk.expert Pro 5 (K190354) | Cyden Limited | 2019-03-18 |
| The Progressive Orthopaedic Company Total Knee System II (K183344) | The Progressive Orthopaedic Company, LLC | 2019-03-18 |
| Sensilight Pro / Pistol IPL (K183260) | El Global Trade, Ltd. | 2019-03-18 |
| Sonendo GentleWave System (K190359) | Sonendo, Inc. | 2019-03-16 |
| MOBILETT Elara Max (K182639) | Siemens Medi Cal Solutions, Inc. | 2019-03-15 |
| ApexMV (K182022) | Incontrol Medical, LLC | 2019-03-15 |
| COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT (K182813) | Cotton High Tech S.L. | 2019-03-15 |
| MTF Pre-Sutured Tendon (K181633) | Musculoskeletal Transplant Foundation | 2019-03-15 |
| Vantage Galan 3T, MRT-3020/A9, V5.0 (K183657) | Canon Medical Systems Corporation | 2019-03-15 |
| MectaLIF Anterior Stand Alone Extension (K183426) | Medacta International S.A. | 2019-03-15 |
| SonialVision G4 (K190373) | Shimadzu Corporation | 2019-03-15 |
| Parcus Twist AP Suture Anchors (K183501) | Parcus Medical, LLC | 2019-03-15 |
| nextaro Transfer System, nextaro va (K183187) | Sfm Medical Devices GmbH | 2019-03-15 |
| TCAT (R) THA Instrument Tray Set (K180127) | THINK Surgical, Inc. | 2019-03-15 |
| CELL-DYN Emerald 22 AL System (K190294) | Abbott Laboratories | 2019-03-15 |
| MAMBA and MAMBA Flex Microcatheters (K190401) | Boston Scientific Corporation | 2019-03-15 |
| HORIZON TMS Therapy System (K182853) | Magstim Company, Ltd. | 2019-03-15 |
| Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch (K190099) | Corinth Medtech, Inc. | 2019-03-15 |
| CardioFlux with Faraday Analytical Cloud (K182571) | Genetesis, Inc. | 2019-03-15 |
| SelectSite C304-HIS Deflectable Catheter System (K183493) | Medtronic, Inc. | 2019-03-15 |
| Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly (K190280) | Total Joint Orthopedics, Inc. | 2019-03-15 |
| FUJIFILM Sonosite Vevo MD Imaging System (K190476) | FUJIFILM Sonosite, Inc. | 2019-03-15 |
| HIVOX OTC Electrical Stimulator (K190347) | Hivox Biotek, Inc. | 2019-03-15 |
| Star-X, Intraoral X-ray System (K190357) | Hdx Will Corp. | 2019-03-15 |
| JKH Stimulator Plus (K182203) | Jkh USA, LLC | 2019-03-14 |
| VITROS XT Chemistry Products UREA-CREA Slides (K190326) | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 |
| Vstrip H. pylori Antigen Rapid Test (K183573) | Panion & BF Biotech, Inc. | 2019-03-14 |
| Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) | Omron Healthcare, Inc. | 2019-03-14 |
| ClearMate (DEN170044) | Thornhill Research, Inc. | 2019-03-14 |
| Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) (K182475) | Covidien | 2019-03-14 |
| dpl Faceware (K183247) | Led Technologies, Inc. | 2019-03-14 |
| PROSTIM Injectable Inductive Graft (K190283) | Wrightmedicaltechnologyinc | 2019-03-14 |
| VASOBand Vascular Compression Device (K190318) | Vasoinnovations, Inc. | 2019-03-14 |
| ConvertX Biliary Stent System (K181669) | Brightwater Medical | 2019-03-14 |
| da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K182371) | Intuitive Surgical, Inc. | 2019-03-14 |
| Aquas Probes (K190168) | Genicon, Inc. | 2019-03-14 |
| EUROPA Pedicle Screw System (K180337) | MiRus, LLC | 2019-03-14 |
| PathVisionXL (K183142) | Faxitron Bioptics, LLC | 2019-03-14 |
| Tetric PowerFill (K183380) | Ivoclar Vivadent, AG | 2019-03-14 |
| L300 Go System (K190285) | Bioness, Inc. | 2019-03-14 |
| BD Plastipak Syringe (K182589) | Becton, Dickinson and Company | 2019-03-14 |
| MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) (K182920) | MiRus, LLC | 2019-03-13 |
| Wright Jones Fracture System (K183026) | Wrightmedicaltechnologyinc | 2019-03-13 |
| Alteon Acetabular Cup System (K182502) | Exactech, Inc. | 2019-03-13 |
| Anchor Bag-Alone Tissue Retrieval System by ConMed (K183600) | Conmed Corporation | 2019-03-13 |
| JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor (K183492) | Nanjing Jusha Display Technology Co., Ltd. | 2019-03-13 |
| BIOK7600W Wireless Flat Panel Detector (K190300) | Biokinemetrics, Inc. | 2019-03-13 |
| Enhanced Feature Software Pack CXDI Series (K190368) | Canon, Inc. | 2019-03-13 |
| Venture 0.014 Catheter (K182570) | Vascular Solutions, LLC | 2019-03-13 |
| BeneVision Central Monitoring System (K183238) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-13 |
| BIOK7600 Flat Panel Detector (K190311) | Biokinemetrics, Inc. | 2019-03-13 |
| DePuy Synthes Maxillofacial Portfolio - MR Conditional (K183113) | Synthes (USA) Products, LLC | 2019-03-13 |
| Modular Spinal Fixation System (K183430) | Life Spine, Inc. | 2019-03-13 |
| DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional (K183472) | Synthes (USA) Products, LLC | 2019-03-13 |
| AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm (K183463) | Stryker | 2019-03-13 |
| AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) (K183464) | Stryker | 2019-03-13 |