| K190113 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. Apr 24, 2019 |
| K190043 — Halley resin | Dentsply Sirona Apr 24, 2019 |
| K183679 — Occlusion Balloon Catheter | Qxmedical, LLC Apr 24, 2019 |
| K190789 — IntelliCartTM System | Dornoch Medical Systems Apr 24, 2019 |
| K190375 — Parcus ATLAS | Parcus Medical, LLC Apr 24, 2019 |
| K173065 — A&D Medical Blood Pressure Monitors | A&D Company, Ltd. Apr 24, 2019 |
| K190496 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. Apr 24, 2019 |
| K183156 — V-Laser | Wontech Co., Ltd. Apr 24, 2019 |
| K181971 — Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | Cook Incorporated Apr 23, 2019 |
| K190110 — NanoBone SBX PUTTY, NanoBone QD | Artoss GmbH Apr 23, 2019 |
| K190489 — Elcam Stopcocks and Manifolds | Elcam Medical Acal Apr 23, 2019 |
| K182723 — Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. Apr 23, 2019 |
| K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Advanced Sterilization Products (Asp) Apr 23, 2019 |
| K182386 — Reprocessed Supreme Diagnostic Electrophysiology Catheter | Innovative Health, LLC Apr 23, 2019 |
| K190753 — EverCrossTM 0.035 OTW PTA Dilatation Catheter | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) Apr 23, 2019 |
| K190621 — SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long | Sumitomo Bakelite Co., Ltd. Apr 23, 2019 |
| K190407 — CryoLab | Cryoconcepts LP Apr 22, 2019 |
| K182778 — LC GLOSSFILL XR | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH Apr 22, 2019 |
| K182513 — FluChip-8G Influenza A+B Assay | Indevr, Inc. Apr 22, 2019 |
| K182516 — Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp Apr 22, 2019 |
| K183613 — exGraft, exGraft Carbon | Peca Labs Apr 22, 2019 |
| K183090 — Relieva Tract Balloon Dilation System | Acclarent, Inc. Apr 19, 2019 |
| K190463 — Cepheid Xpert C. difficile/Epi Control Panel | Microbiologics, Inc. Apr 19, 2019 |
| K183192 — CapsoCam Plus (SV-3) | CapsoVision, Inc. Apr 19, 2019 |
| K190415 — ATLAS Plating System | MiRus, LLC Apr 19, 2019 |
| K190729 — SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part Of Stryker) Apr 19, 2019 |
| K180065 — FUSION Plus Curing Light | Dentlight, Inc. Apr 19, 2019 |
| K190791 — Ez3D-i/E3 | Ewoosoft Co., Ltd. Apr 19, 2019 |
| DEN180041 — Monarch eTNS System | Neurosigma, Inc. Apr 19, 2019 |
| K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. Apr 19, 2019 |
| K183056 — ASSURE® Anterior Cervical Plate System | Globus Medical, Inc. Apr 19, 2019 |
| DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units | Kci USA, Inc. Apr 19, 2019 |
| K181747 — Orthodontic Appliance | Shandong Huge Dental Material Corporation Apr 18, 2019 |
| K182103 — Psychemedics Microplate EIA for Fentanyl in Hair | Psychemedics Corporation Apr 18, 2019 |
| K190109 — MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) | Beckman Coulter, Inc. Apr 18, 2019 |
| K190788 — Disposable Standard Clamp | Standard Bariatrics Apr 18, 2019 |
| K190644 — Guide Sheath | Surmodics,Inc. Apr 18, 2019 |
| K182457 — Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J | Brivant Limited (Lake Region Medical) Apr 18, 2019 |
| K190364 — CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC Apr 18, 2019 |
| K183593 — Lung Vision System | Bodyvision Medical , Ltd. Apr 18, 2019 |
| K190506 — NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. Apr 18, 2019 |
| K183601 — CryoTouch | Cryoconcepts LP Apr 18, 2019 |
| K182702 — SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I., Inc. Apr 17, 2019 |
| K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. Apr 17, 2019 |
| K183043 — 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter | Imperative Care, Inc. Apr 17, 2019 |
| K183634 — Stasis Monitoring System | Stasis Labs, Inc. Apr 17, 2019 |
| K181988 — eMurmur ID | Csd Labs GmbH Apr 17, 2019 |
| K190693 — HEM-6410T-ZL Wrist Blood Pressure Monitor | Omron Healthcare, Inc. Apr 17, 2019 |
| K183403 — JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC Apr 17, 2019 |
| K190369 — M-Y Sheath | Ram Medical Innovations, Inc. Apr 17, 2019 |