| RadCalc Software (K193381) | Lifeline Software, Inc. | 2019-12-31 |
| AutoMIStar (K192912) | Apollo Medical Imaging Technology Pty. , Ltd. | 2019-12-31 |
| InCore TMT System (K192578) | Nextremity Solutions, Inc. | 2019-12-31 |
| Patient Monitor (K192343) | Shenzhen Creative Industry Co., Ltd. | 2019-12-31 |
| Digital Thermometer (K190990) | Xiamen Ants Bro Technology Co., Ltd. | 2019-12-31 |
| mCare® Powder Free Nitrile Black Examination Glove (K192444) | Mercator Medical (Thailand), Ltd. | 2019-12-31 |
| Disposable Valve Sets (K192258) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2019-12-30 |
| Depuy Synthes Maxillofacial Portfolio - MR Conditional (K192655) | Synthes (USA) Products, LLC | 2019-12-30 |
| Sterile Latex Surgical Glove, Powder Free (K190241) | Careglove Global Sdn. Bhd. | 2019-12-30 |
| Masimo Rad-97 and Accessories (K191059) | Masimo Corporation | 2019-12-27 |
| Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (K191696) | Cook Biotech Incorporated | 2019-12-27 |
| Volumetric Specimen Imager (K192939) | Clarix Imaging | 2019-12-27 |
| True 3D Viewer Software (K193149) | Echopixel, Inc. | 2019-12-27 |
| Xcam (K192700) | Hdx Will Corp. | 2019-12-27 |
| UroNav System (K193403) | Invivo Corporation | 2019-12-27 |
| Straumann BLX Ø3.5 mm Implants (K191256) | Institut Straumann AG | 2019-12-27 |
| Medical Radiation Dosimetry System microSTARii (K192196) | Landauer | 2019-12-27 |
| InMode System with the Morpheus8 (Fractora) Applicators (K192695) | Inmode MD , Ltd. | 2019-12-27 |
| Temporary Fixation Pins (K192768) | Eisertech, LLC | 2019-12-26 |
| TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (K190884) | Datascope Corp. | 2019-12-26 |
| iHelmet Hair Growth System (K190467) | Slinph Technologies Co., Ltd. | 2019-12-26 |
| Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem (K193050) | Zimmer GmbH | 2019-12-26 |
| VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) (K192135) | MicroVention, Inc. | 2019-12-24 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| RelieforMe TENS/EMS Device Model UPK-GE01 (K192733) | Umeheal , Ltd. | 2019-12-23 |
| Arthrex Univers Revers Modular Glenoid System (K191960) | Arthrex, Inc. | 2019-12-23 |
| Mucosal Integrity Conductivity (MI) Test System (DEN180067) | Diversatek Healthcare, Inc. | 2019-12-23 |
| Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs (K190736) | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 |
| MAXReach Laser Probe (K191846) | Vortex Surgical, Inc. | 2019-12-23 |
| Arm Blood Pressure Monitor (K192023) | Truly Instrument Limited | 2019-12-23 |
| BioCode Respiratory Pathogen Panel (RPP) (K192485) | Applied BioCode, Inc. | 2019-12-23 |
| Mini and Micro Fragments Reconstruction System – GMReis (K182718) | Gm Dos Reis Industria E Comerico Ltda. | 2019-12-23 |
| EZ-TRAX Containment Device (K192487) | K1 Medical, LLC | 2019-12-23 |
| RIST Cath Radial Access Long Sheath (K191551) | Rist Neurovascular, Inc. | 2019-12-23 |
| Trigon™ Ti Stand-Alone Wedge Fixation System (K192645) | Nvision Biomedical Technologies, Inc. | 2019-12-23 |
| 3M Attest Steam Chemical Integrator (K193254) | 3M Company | 2019-12-23 |
| Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color (K190860) | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 |
| Neodent Instrument Kit Cases (K190665) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-23 |
| Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) (K192104) | Medline Industries, Inc. | 2019-12-23 |
| Spinalytics (K192629) | Optima Health Solutions International Corp. | 2019-12-21 |
| Acetabular Bone Screws (for MobileLink Acetabular Cup System) (K192559) | Waldemar Link GmbH & Co. KG | 2019-12-21 |
| Ziehm Vision FD (K193230) | Ziehm Imaging GmbH | 2019-12-20 |
| Bengal Stackable Cage System (K190284) | Medos International SARL | 2019-12-20 |
| Dannik Titanium Ligation Clip (K192711) | Dannik | 2019-12-20 |
| NanoOrtho NanoKnee® System (K190633) | Nanoortho, LLC | 2019-12-20 |
| Paragonix SherpaPak Pancreas Transport System (K191440) | Paragonix Technologies | 2019-12-20 |
| Surgical Direct Hand-held Laparoscopic Instruments (K193018) | Surgical Direct, Inc. | 2019-12-20 |
| Indigo Aspiration System (K192833) | Penumbra, Inc. | 2019-12-20 |
| Voyant 5mm Fusion Device, Voyant Maryland Fusion Device (K193292) | Applied Medical Resources Corp. | 2019-12-20 |
| Litho Evo (K192990) | Quanta System Spa | 2019-12-20 |
| xvision Spine system (XVS) (K190929) | Augmedics, Ltd. | 2019-12-20 |
| ACTIVE® Free Testosterone RIA (K191350) | Immunotech S.R.O. | 2019-12-20 |
| R&D Series Nova Compo N (K192178) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2019-12-20 |
| Pulse Oximeter (K191403) | Nonin Medical, Inc. | 2019-12-20 |
| APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets (K191234) | Erbe Elektromedizin GmbH | 2019-12-20 |
| IODOSORB (K190730) | Smith & Nephew Medical, Ltd. | 2019-12-20 |
| IceSense 3, ProSense, MultiSense (K183213) | IceCure Medical , Ltd. | 2019-12-20 |
| Unyvero LRT BAL Application (K191967) | Curetis GmbH | 2019-12-20 |
| MRopen EVO (K193116) | Asg Superconductors S.P.A. | 2019-12-20 |
| Soli-Lite LG4 Galileo (K192755) | Silhouet-Tone Corporation | 2019-12-20 |
| Ceramill A-Splint (K191836) | Amann Girrbach AG | 2019-12-20 |
| PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL (K190805) | Pentax of America, Inc. | 2019-12-20 |
| RHIN1 Stylus (K192471) | Aerin Medical, Inc. | 2019-12-20 |
| Unscented W long plastic and cardboard applicator tampons (K191666) | Ontex Bvba | 2019-12-20 |
| Nexus DR Digital X-Ray Imaging System (with vSharp) (K193238) | Varex Imaging Corporation | 2019-12-20 |
| Carescape One (K190008) | GE Healthcare | 2019-12-20 |
| Telepack + (K193235) | Karl Storz Endoscopy America, Inc. | 2019-12-20 |
| Clear-Aligners (K191823) | Cdb Corporation | 2019-12-20 |
| AVIEW Modeler (K192040) | Coreline Soft Co., Ltd. | 2019-12-20 |
| QLAB Advanced Quantification Software (K191647) | Philips Health Care | 2019-12-20 |
| Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology (K192718) | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019-12-20 |
| IODOFLEX (K190756) | Smith & Nephew Medical, Ltd. | 2019-12-20 |
| WEREWOLF COBLATION System, COBLATION HALO Wand (K192027) | ArthroCare Corporation | 2019-12-20 |
| UroLift System (UL400) (K193269) | Neotract, Inc. | 2019-12-20 |
| DenMat Orthodontic Aligners (K192470) | Denmat Holdings, LLC | 2019-12-20 |
| SX-One MicroKnife (K192873) | Sonex Health, Inc. | 2019-12-20 |
| Non-Sterile Zirconia Block (K190112) | Fine Advanced Compound Co., Ltd. | 2019-12-20 |
| BriefCase (K192383) | Aidoc Medical , Ltd. | 2019-12-20 |
| DRX-Evolution with Carestream Digital Tomosynthesis (K191879) | Carestream Health, Inc. | 2019-12-20 |
| LiteWalk (K192607) | Viasonix , Ltd. | 2019-12-19 |
| uMC 560i (K183144) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-12-19 |
| ZOLL Arrhythmia Management Sysyem (K190939) | Zoll Manufacturing Corporation | 2019-12-19 |
| Albumin BCP (K193001) | SENTINEL CH. SpA | 2019-12-19 |
| ZS3 and z.one pro Ultrasound Systems (K192410) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-12-19 |
| The RHEA Vital Sign Vigilance System (K190775) | Shenzhen Fiber Medical Technology Co. , Ltd. | 2019-12-19 |
| Krystal Klear Aligners (K182388) | Shatkin F.I.R.S.T., LLC | 2019-12-19 |
| Monopolar Cord (K193004) | New Deantronics Taiwan , Ltd. | 2019-12-19 |
| Neodent Implant System- GM Titanium Base for Bridge (K192229) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-19 |
| Halo One Thin-Walled Guiding Sheath (K192313) | C.R. Bard, Inc. | 2019-12-19 |
| Everyway OTC TENS/EMS Combination (K192589) | Everyway Medical Instruments Co.,Ltd | 2019-12-19 |
| Hereaeus Poseidon Microcatheter (K191305) | Heraeus Medical Components, LLC | 2019-12-19 |
| Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314) | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 |
| 4CIS Marlin PEEK ACIF Cage (K192044) | Solco Biomedical Co., Ltd. | 2019-12-19 |
| EZER, Portable X-ray System (K190935) | Livermoretech, Inc. | 2019-12-19 |
| Spinal Elements Navigated Instruments (K190881) | Spinal Elements, Inc. | 2019-12-19 |
| Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) (K190829) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019-12-19 |
| TK Sterile Hypodermic Needle (K191643) | Anhui Tiankang Medical Technology Co., Ltd. | 2019-12-19 |
| DentiqAir (K183676) | 3D Industrial Imaging Co., Ltd. | 2019-12-19 |
| Aveta Disposable Hysteroscope (K192100) | Meditrina, Inc. | 2019-12-19 |
| Electronic Stethoscope (K191667) | Hefei Mintti Medical Technology Co., Ltd. China | 2019-12-18 |