| BioSticker System (K191614) | Biointellisense, Inc. | 2019-12-18 |
| Neodent Instrument Kit Cases (K192670) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-18 |
| OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid (K190012) | Medtrade Product, Ltd. | 2019-12-18 |
| Avenir Complete Hip System, Size 0 Coxa Vara (K192189) | Zimmer, Inc. | 2019-12-18 |
| BEACON Caresystem Model 00002144 (K192584) | Mermaid Care A/S | 2019-12-18 |
| Percusys® Plus Pedicle Screw System (K192680) | Joimax GmbH | 2019-12-18 |
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (K182476) | Fengh Medical Co., Ltd. | 2019-12-18 |
| Sterile Latex Powder-Free Surgical Gloves (K191898) | Modern Healthcare Corp. | 2019-12-18 |
| STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device (K192580) | ETHICON, Inc. | 2019-12-18 |
| IntraMarX Radiopaque Markers (K191087) | Anx Robotica Corp | 2019-12-18 |
| Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric (K190824) | Bluepoint Medical GmbH & Co. KG | 2019-12-18 |
| ILUMIEN System with AptiVue Software version D.3 (K192267) | ABBOTT MEDICAL | 2019-12-17 |
| InMode System with Tone Applicator (K192249) | InMode , Ltd. | 2019-12-17 |
| Bashir Plus Endovascular Catheter (K193071) | Thrombolex, Inc. | 2019-12-17 |
| Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) (K192615) | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019-12-17 |
| EV1000 Clinical Platform (K193179) | Edwards Lifesciences, LLC | 2019-12-17 |
| syngo.CT CaScoring (K192763) | Siemens Medical Solutions USA, Inc. | 2019-12-17 |
| ExSpiron 2Xi (K192595) | Respiratory Motion | 2019-12-17 |
| Single Use Balloon Dilator V (with knife) (K193039) | Olympus Medical Systems Corp. | 2019-12-17 |
| G Surgical Marksman System (K193219) | G Surgical, LLC | 2019-12-17 |
| CNS Envision (K192572) | Moberg Research, Inc. | 2019-12-17 |
| Precision Casting Solutions Total Hip System (K192450) | Precision Casting Solution, LLC | 2019-12-17 |
| Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K191758) | Argon Medical Devices, Inc. | 2019-12-17 |
| Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725) | Riverstone Resources Sdn Bhd | 2019-12-17 |
| EM Provisional (K191751) | Hiossen, Inc. | 2019-12-16 |
| SunClear Aligner system (K190394) | Sun Dental Laboratories, LLC | 2019-12-16 |
| Physio Flex Annuloplasty Ring (K192762) | Edwards Lifesciences, LLC | 2019-12-16 |
| CEDIA Heroin Metabolite (6-AM) assay (K192943) | Microgenics Corporation | 2019-12-16 |
| Stand-Alone ALIF Titanium System (K191834) | Life Spine, Inc. | 2019-12-16 |
| CORRIDOR Fixation System (K192744) | Globus Medical, Inc. | 2019-12-16 |
| Pantheon Spinal Pontus Interbody Fusion Device (K181548) | Pantheon Spinal | 2019-12-16 |
| Deka Luxea (K192539) | El.En Electronic Engineering Spa | 2019-12-16 |
| Lawson Retrograde Nephrostomy Wire Puncture Set (K190903) | Cook Incorporated | 2019-12-16 |
| Keos Lumbar IBFD (K193174) | Keos | 2019-12-16 |
| Llis, Vittra APS (K191306) | Dentscare Ltda | 2019-12-16 |
| AXS Vecta Aspiration Catheter (K190833) | Stryker Neurovascular | 2019-12-15 |
| Airlock Centrolock Osteosynthesis Implant System (K192356) | Novastep | 2019-12-14 |
| neria guard Infusion Set (K192647) | Unomedical A/S | 2019-12-13 |
| CareView 1800Le (K193173) | Careray Digital Medical System Co., Ltd. | 2019-12-13 |
| DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System (K192152) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-12-13 |
| MyShoulder Placement Guides (K190738) | Medacta International S.A. | 2019-12-13 |
| Diode Laser Therapy System (K192569) | San HE Lefis Electronics Co., Ltd. | 2019-12-13 |
| ReliOn Premier Classic Blood Glucose Monitoring System (K192220) | I-Sens, Inc. | 2019-12-13 |
| EPIFLO-28 (K190742) | Neogenix, LLC Dba Ogenix | 2019-12-13 |
| Control-IQ Technology (DEN190034) | Tandem Diabetes Care, Inc. | 2019-12-13 |
| EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand (K190715) | Interscope, Inc. | 2019-12-13 |
| decimal3D (K192554) | .Decimal, LLC | 2019-12-13 |
| CrossTorq 14 Guidewire (K193194) | Scientia Cardio Access, LLC | 2019-12-13 |
| Aero Blue Performance Surgical Gowns (K192362) | O&M Halyard, Inc. | 2019-12-13 |
| MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (K192370) | Bayer Medical Care, Inc. | 2019-12-13 |
| Infrared Thermometer, model: PC808 (K190717) | Shenzhen Pacom Medical Instruments Co., Ltd. | 2019-12-13 |
| Deep Learning Image Reconstruction (K193170) | Ge Healthcare Japan Corporation | 2019-12-13 |
| QyScore Software (K192531) | Qynapse | 2019-12-13 |
| Satisfaite (K190752) | Femmepharma Consumer Healthcare, LLC | 2019-12-13 |
| Neo Cage System (K191796) | Neo Medical SA | 2019-12-13 |
| EPi-Sense Guided Coagulation System with VisiTrax (K193162) | AtriCure, Inc. | 2019-12-13 |
| Laser Hair Growth Cap (K192627) | Shang FA Biotechnology Co. | 2019-12-13 |
| Avanti Distal Radius and Forearm System (K191118) | Avanti Orthopaedics, Inc. | 2019-12-13 |
| Corelink Navigation Instruments (K182731) | Corelink, LLC | 2019-12-13 |
| EXALT Model D Single-Use Duodenoscope, EXALT Controller (K193202) | Boston Scientific Corporation | 2019-12-13 |
| CoreLite X-Ray Specimen Cabinet (K193317) | Cirdan Imaging Limited | 2019-12-13 |
| C50 and C80 Multi-parameter Patient Monitor (K191106) | Shenzhen Comen Medical Instruments Co.,Ltd | 2019-12-13 |
| Demetra BDEM-01 Dermatoscope (K192829) | Barco N.V. | 2019-12-13 |
| VaPro Plus Pocket, VaPro Plus (K193148) | Hollister Incorporated | 2019-12-13 |
| Icobrain (K192130) | Icometrix NV | 2019-12-13 |
| Ambar, Ambar APS, Ambar Universal APS (K183424) | Dentscare Ltda | 2019-12-13 |
| Tri-Ex Extraction Balloon with Multiple Sizing (K193344) | Wilson-Cook Medical, Inc. | 2019-12-13 |
| BIO-C Sealer Ion+ (K190537) | Angelus Industria DE Produtos Odontologicos S/A | 2019-12-12 |
| OptoMonitor (K192340) | Opsens, Inc. | 2019-12-12 |
| Genesys Spine 3DP Lumbar Interbody System (K182987) | Genesys Spine | 2019-12-12 |
| GSP Neonatal Creatine Kinase - MM kit (DEN180056) | Perkinelmer, Inc. | 2019-12-12 |
| Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133) | Cook Incorporated | 2019-12-12 |
| Arthrex 3.9mm Corkscrew Suture Anchor (K193157) | Arthrex, Inc. | 2019-12-12 |
| Tablo Hemodialysis System, Tablo Cartridge (K190793) | Outset Medical, Inc. | 2019-12-12 |
| Lumax Guiding Catheter (K191163) | Cook Incorporated | 2019-12-12 |
| HS50/HS60 Diagnostics Ultrasound System (K192505) | Samsung Medison Co., Ltd. | 2019-12-12 |
| Invictus™ Spinal Fixation System (K192938) | Alphatec Spine, Inc. | 2019-12-12 |
| Health Expert Electronic Stimulator (K190673) | Shenzhen Osto Technology Company Limited | 2019-12-12 |
| SleepTight Mouthpiece STZ (K191618) | Michael D Williams Dds PA | 2019-12-11 |
| NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167) | Luminex Molecular Diagnostics, Inc. | 2019-12-11 |
| HI-TORQUE InfilTrac Guide Wire Family (K193126) | Abbott Vascular | 2019-12-11 |
| EVO 450 series High Speed Handpieces (K190508) | Ttbio Corp. | 2019-12-11 |
| NemoScan (K192571) | Software Nemotec S.L. | 2019-12-11 |
| MIS Dental Implant System (K192149) | Dentsply Sirona, Inc. | 2019-12-11 |
| Exciplex (K191086) | Clarteis | 2019-12-11 |
| FUJIFILM Distal Cap Models 33-40 (K193123) | Fujifilm Corporation | 2019-12-11 |
| TSolution One Total Knee Application (K193135) | THINK Surgical, Inc. | 2019-12-11 |
| Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter (K191880) | Innovative Health, LLC | 2019-12-11 |
| Endotracheal Tube with Evacuation Lumen (K182739) | Well Lead Medical Co., Ltd. | 2019-12-11 |
| LOSPA II Knee System (K192507) | Corentec Co., Ltd. | 2019-12-11 |
| CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (K193132) | Hangzhou Clongene Biotech Co., Ltd. | 2019-12-11 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K192929) | STERIS Corporation | 2019-12-10 |
| Transpara (K192287) | Screenpoint Medical B.V. | 2019-12-10 |
| Health Line CT CVC (K192533) | Health Line International Corporation | 2019-12-10 |
| HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System (K192319) | Samsung Medison Co., Ltd. | 2019-12-10 |
| Single Use Aspiration Needle (K190239) | Olympus Medical Systems Corp. | 2019-12-10 |
| Diode Laser 808nm (K192516) | Beijing Superlaser Technology Co., Ltd. | 2019-12-10 |
| Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System (K191793) | Nebula Surgical Private Limited | 2019-12-09 |
| Dental high speed handpiece, Dental low speed handpiece (K181900) | Foshan Cicada Dental Instrument Co, Ltd. | 2019-12-09 |
| Straumann Mini Implants (K191895) | Institut Straumann AG | 2019-12-09 |