| CPT Hip System (K191735) | Zimmer, Inc. | 2020-03-20 |
| Bioland Blood Glucose Monitoring System (K191657) | Bioland Technology, Ltd. | 2020-03-20 |
| Encision AEM Monopolar Laparoscopic Instruments and Accessories (K191612) | Encision Incorporated | 2020-03-20 |
| iTero Element 5D (K193659) | Align Technology, Inc. | 2020-03-20 |
| Super Sheath (K200379) | Togo Medikit Co., Ltd. | 2020-03-19 |
| G3 40 Radiopaque Bone Cement (K193061) | G21, S.R.L. | 2020-03-19 |
| Creo Electrosurgical System with HS1 Hemostasis Accessory (K192905) | Creo Medical, Ltd. | 2020-03-19 |
| G1 40 Radiopaque Bone Cement (K193059) | G21, S.R.L. | 2020-03-19 |
| Deklene MAXX (K193530) | Teleflex Medical | 2020-03-19 |
| restor3d Metallic Interference Screw (K193491) | Restor3D | 2020-03-19 |
| Park's Pectus System (K191057) | Tdm Co., Ltd. | 2020-03-19 |
| Compression Therapy Device (K191856) | Guangzhou Longest Science & Technology Co., Ltd. | 2020-03-19 |
| F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) (K191818) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 |
| IV Sets not made with PVC (K191658) | B.Braun Medical, Inc. | 2020-03-19 |
| BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) | Biofire Diagnostics, LLC | 2020-03-18 |
| HEALICOIL Knotless Suture Anchors (K193558) | Smith & Nephew, Inc. | 2020-03-18 |
| speX LP Support Catheter (K200094) | Reflow Medical | 2020-03-18 |
| PulmoScan (K191876) | Cognita Labs, LLC | 2020-03-18 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) (K193536) | Beckman Coulter, Inc. | 2020-03-18 |
| Viz ICH (K193658) | Viz. Ai, Inc. | 2020-03-18 |
| WIRION (K200198) | Cardiovascular Systems, Inc. | 2020-03-18 |
| VIVIX-S VW (K200418) | Vieworks Co., Ltd. | 2020-03-18 |
| LINK TrabecuLink Tibial Cones (K200113) | Waldemar Link GmbH & Co. KG | 2020-03-18 |
| Evolve Breast Pump (K200406) | Hygeia II Medical Group, Inc. | 2020-03-18 |
| Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (K191027) | Maquet Critical Care AB | 2020-03-18 |
| ViziShot 2 FLEX (K193517) | Olympus Surgical Technologies America | 2020-03-18 |
| iBalance UKA Tibial Tray Implant (K200433) | Arthrex, Inc. | 2020-03-17 |
| Shear Wave Quantificational Ultrasound Diagnostic System (K200136) | Wuxi Hisky Medical Technologies Co., Ltd. | 2020-03-17 |
| NeuralScan System (K192753) | Medeia, Inc. | 2020-03-17 |
| myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (K193310) | Abbott (St. Jude Medical) | 2020-03-17 |
| SterilContainer S2 System (K193582) | Aesculap, Inc. | 2020-03-17 |
| EndoTool IV 1.10 (K200443) | Monarch Medical Technologies, LLC | 2020-03-17 |
| ACUVUE (senofilcon A) Soft Contact Lens Multifocal (K200243) | Johnson & Johnson Vision Care, Inc. | 2020-03-17 |
| Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill (K200151) | Zimmer, Inc. | 2020-03-17 |
| Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) (K191753) | Medline Industries, Inc. | 2020-03-17 |
| Wolf445nm (K192272) | A.R.C Laser GmbH | 2020-03-17 |
| TheraBase, TheraBase Ca (K192007) | Bisco, Inc. | 2020-03-17 |
| AERO CHROME* Breathable Performance Surgical Gowns (K200522) | O&M Halyard, Inc. | 2020-03-16 |
| CONTINUUM PACS (K200385) | Integrated Ophthalmic Systems, Inc. | 2020-03-16 |
| Al-Rad Companion (Musculoskeletal) (K193267) | Siemens Medical Solutions USA, Inc. | 2020-03-16 |
| SANDRO Dual (K200110) | Wontech Co., Ltd. | 2020-03-16 |
| Altera Filter and HME/Filter (K192713) | Meditera Tibbi Malzeme San VE Tic AS | 2020-03-16 |
| Epic 980 (K193486) | Biolase, Inc. | 2020-03-16 |
| Transferrin (K190495) | Biosystems S.A. | 2020-03-16 |
| Response BandLoc Spinal Fixation (K200097) | OrthoPediatrics Corp. | 2020-03-16 |
| Sunmed Disposable Angio-Closure Pads (K191827) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020-03-16 |
| OptikView GUP2103CMI (K191705) | The Linden Group Corp | 2020-03-16 |
| AnatomicAligner (K190767) | The Methodist Hospital Research Institute D/B/A Houston | 2020-03-16 |
| Health Expert Electronic Stimulator (model: AST-300L) (K190783) | Shenzhen Osto Technology Company Limited | 2020-03-14 |
| 3DMetal Diaphyseal Femoral Cones (K200075) | Medacta International S.A. | 2020-03-13 |
| Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches (K193325) | Prosys International, Ltd. | 2020-03-13 |
| Stat Profile Prime Plus Analyzer System (K200349) | Nova Biomedical Corporation | 2020-03-13 |
| Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula (K200358) | Edwards Lifesciences, LLC | 2020-03-13 |
| PrisMax System Version 3 (K193482) | Baxter Healthcare Corporation | 2020-03-13 |
| iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (K193105) | Conformis, Inc. | 2020-03-13 |
| GIA Stapler with Tri-Staple Technology (K192720) | Covidien | 2020-03-13 |
| Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192241) | O&M Haylard, Inc. | 2020-03-13 |
| CS 9600 (K200183) | Trophy | 2020-03-13 |
| MeDioStar (K192483) | Asclepion Laser Technologies GmbH | 2020-03-13 |
| VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (K193572) | bioMerieux, Inc. | 2020-03-13 |
| Curian HpSA, Curian Analyzer (K192817) | Meridian Bioscience, Inc. | 2020-03-13 |
| Disposable SpO2 Sensor (K200069) | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-13 |
| LEGION Inserts with JRNY Lock (K200407) | Smith & Nephew, Inc. | 2020-03-13 |
| 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 (K191869) | Molnlycke Health Care Us, LLC | 2020-03-13 |
| 32HL512D (K192925) | Lg Electronics.Inc | 2020-03-13 |
| EzOrtho (K192888) | Ewoosoft Co., Ltd. | 2020-03-13 |
| Indigo Aspiration System – Lightning Aspiration Tubing (K193244) | Penumbra, Inc. | 2020-03-13 |
| NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate (K192162) | Neurovention, LLC | 2020-03-13 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K193110) | 3M Healthcare | 2020-03-13 |
| SeaSpine Skipjack System (K193418) | SeaSpine Orthopedics Corporation | 2020-03-13 |
| elysion-pro (K193367) | High Technology Products S.L.U | 2020-03-12 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml (K193538) | Thermo Fisher Scientific | 2020-03-12 |
| Health Line CT Midline Catheter (K200263) | Health Line International Corporation | 2020-03-12 |
| Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (K191638) | Medtest DX | 2020-03-12 |
| SpaceStation MRI (K191910) | B. Braun Melsugen AG | 2020-03-12 |
| Arthrex FiberTak Suture Anchor (K200341) | Arthrex, Inc. | 2020-03-12 |
| BioNourish Lubricant (K193448) | Good Clean Love, Inc. | 2020-03-12 |
| SonoVision Ultrasound Imaging System (K192388) | Tissue Differentiation Intelligence, LLC | 2020-03-12 |
| RefleXion Medical Radiotherapy System (K190978) | Reflexion Medical, Inc. | 2020-03-12 |
| AMT Suture Delivery System (K193612) | Applied Medical Technology, Inc. | 2020-03-12 |
| NEOLab Clear Aligners (K192338) | New England Ortho Lab, Inc. | 2020-03-12 |
| Tritium Sternal Cable Plate System (K193468) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-03-12 |
| Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K200328) | Kyocera Medical Technologies, Inc. | 2020-03-11 |
| MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit (K192924) | Siemens Medical Solutions USA, Inc. | 2020-03-11 |
| AC5 Topical Gel (K190129) | Arch Therapeutics, Inc. | 2020-03-11 |
| Vista Dyes (K193447) | Inter-Med/Vista Dental Products | 2020-03-11 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K192979) | KLS-Martin L.P. | 2020-03-11 |
| Fixone Biocomposite Anchor (K192484) | Aju Pharm Co., Ltd. | 2020-03-11 |
| Quidel Triage® TOX Drug Screen, 94600 (K200363) | Quidel Cardiovascular, Inc. | 2020-03-11 |
| Apollo Suture Anchor System (K192810) | Valeris Medical | 2020-03-11 |
| 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 (K200370) | Centers for Disease Control and Prevention | 2020-03-10 |
| AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (K193481) | International Biomedical | 2020-03-10 |
| FlexPointer 1.5 Single Use, FlexTube 3 Single Use (K200041) | Fiagon GmbH | 2020-03-10 |
| JR.MEDIK Latex Surgeon’s Gloves Powder Free (K192328) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020-03-10 |
| Bare: 808 (K193446) | Luvo Medical Technologies, Inc. | 2020-03-10 |
| Rapid Acoustic Pulse Device (K200331) | Soliton, Inc. | 2020-03-10 |
| Elecsys BRAHMS PCT (K192815) | Roche Diagnostics | 2020-03-09 |
| Elite iQ (K193426) | Cynosure, LLC | 2020-03-09 |
| MectaLIF Anterior Simple (K200048) | Medacta International S.A. | 2020-03-09 |
| syngo.CT Lung CAD (K193216) | Siemens Medi Cal Solutions, Inc. | 2020-03-09 |