| K192483 — MeDioStar | Asclepion Laser Technologies GmbH Mar 13, 2020 |
| K192888 — EzOrtho | Ewoosoft Co., Ltd. Mar 13, 2020 |
| K192720 — GIA Stapler with Tri-Staple Technology | Covidien Mar 13, 2020 |
| K200358 — Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula | Edwards Lifesciences, LLC Mar 13, 2020 |
| K200069 — Disposable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. Mar 13, 2020 |
| K192925 — 32HL512D | Lg Electronics.Inc Mar 13, 2020 |
| K193105 — iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | Conformis, Inc. Mar 13, 2020 |
| K200407 — LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. Mar 13, 2020 |
| K192241 — Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | O&M Haylard, Inc. Mar 13, 2020 |
| K193325 — Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches | Prosys International, Ltd. Mar 13, 2020 |
| K200183 — CS 9600 | Trophy Mar 13, 2020 |
| K193244 — Indigo Aspiration System Lightning Aspiration Tubing | Penumbra, Inc. Mar 13, 2020 |
| K193482 — PrisMax System Version 3 | Baxter Healthcare Corporation Mar 13, 2020 |
| K193572 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) | bioMerieux, Inc. Mar 13, 2020 |
| K200349 — Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation Mar 13, 2020 |
| K200075 — 3DMetal Diaphyseal Femoral Cones | Medacta International S.A. Mar 13, 2020 |
| K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care Us, LLC Mar 13, 2020 |
| K192817 — Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. Mar 13, 2020 |
| K193418 — SeaSpine Skipjack System | SeaSpine Orthopedics Corporation Mar 13, 2020 |
| K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare Mar 13, 2020 |
| K193612 — AMT Suture Delivery System | Applied Medical Technology, Inc. Mar 12, 2020 |
| K192388 — SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC Mar 12, 2020 |
| K193448 — BioNourish Lubricant | Good Clean Love, Inc. Mar 12, 2020 |
| K193367 — elysion-pro | High Technology Products S.L.U Mar 12, 2020 |
| K193468 — Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) Mar 12, 2020 |
| K200263 — Health Line CT Midline Catheter | Health Line International Corporation Mar 12, 2020 |
| K191910 — SpaceStation MRI | B. Braun Melsugen AG Mar 12, 2020 |
| K193538 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml | Thermo Fisher Scientific Mar 12, 2020 |
| K192338 — NEOLab Clear Aligners | New England Ortho Lab, Inc. Mar 12, 2020 |
| K200341 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Mar 12, 2020 |
| K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX Mar 12, 2020 |
| K190978 — RefleXion Medical Radiotherapy System | Reflexion Medical, Inc. Mar 12, 2020 |
| K192924 — MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. Mar 11, 2020 |
| K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. Mar 11, 2020 |
| K200363 — Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. Mar 11, 2020 |
| K193447 — Vista Dyes | Inter-Med/Vista Dental Products Mar 11, 2020 |
| K192979 — KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. Mar 11, 2020 |
| K192484 — Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. Mar 11, 2020 |
| K190129 — AC5 Topical Gel | Arch Therapeutics, Inc. Mar 11, 2020 |
| K192810 — Apollo Suture Anchor System | Valeris Medical Mar 11, 2020 |
| K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical Mar 10, 2020 |
| K192328 — JR.MEDIK Latex Surgeons Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. Mar 10, 2020 |
| K193446 — Bare: 808 | Luvo Medical Technologies, Inc. Mar 10, 2020 |
| K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | Centers For Disease Control And Prevention Mar 10, 2020 |
| K200331 — Rapid Acoustic Pulse Device | Soliton, Inc. Mar 10, 2020 |
| K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH Mar 10, 2020 |
| K200258 — Edwards eSheath Introducer Set | Edwards Lifesciences Mar 9, 2020 |
| K192815 — Elecsys BRAHMS PCT | Roche Diagnostics Mar 9, 2020 |
| K183570 — LiquiBand Plus | Advanced Medical Solutions Limited Mar 9, 2020 |
| K193425 — Pre-Milled Blank | Arum Dentistry Co., Ltd. Mar 9, 2020 |