| K183213 — IceSense 3, ProSense, MultiSense | IceCure Medical , Ltd. Dec 20, 2019 |
| K191647 — QLAB Advanced Quantification Software | Philips Health Care Dec 20, 2019 |
| K191440 — Paragonix SherpaPak Pancreas Transport System | Paragonix Technologies Dec 20, 2019 |
| K192027 — WEREWOLF COBLATION System, COBLATION HALO Wand | ArthroCare Corporation Dec 20, 2019 |
| K192873 — SX-One MicroKnife | Sonex Health, Inc. Dec 20, 2019 |
| K190929 — xvision Spine system (XVS) | Augmedics, Ltd. Dec 20, 2019 |
| K192040 — AVIEW Modeler | Coreline Soft Co., Ltd. Dec 20, 2019 |
| K190112 — Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. Dec 20, 2019 |
| K190756 — IODOFLEX | Smith & Nephew Medical, Ltd. Dec 20, 2019 |
| K192990 — Litho Evo | Quanta System Spa Dec 20, 2019 |
| K190805 — 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 | Pentax Of America, Inc. Dec 20, 2019 |
| K193116 — MRopen EVO | Asg Superconductors S.P.A. Dec 20, 2019 |
| K193292 — Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | Applied Medical Resources Corp. Dec 20, 2019 |
| K192755 — Soli-Lite LG4 Galileo | Silhouet-Tone Corporation Dec 20, 2019 |
| K191967 — Unyvero LRT BAL Application | Curetis GmbH Dec 20, 2019 |
| K191879 — DRX-Evolution with Carestream Digital Tomosynthesis | Carestream Health, Inc. Dec 20, 2019 |
| K192178 — R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS Dec 20, 2019 |
| K191234 — APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets | Erbe Elektromedizin GmbH Dec 20, 2019 |
| K193018 — Surgical Direct Hand-held Laparoscopic Instruments | Surgical Direct, Inc. Dec 20, 2019 |
| K191403 — Pulse Oximeter | Nonin Medical, Inc. Dec 20, 2019 |
| K192718 — Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. Dec 20, 2019 |
| K191350 — ACTIVE® Free Testosterone RIA | Immunotech S.R.O. Dec 20, 2019 |
| K193269 — UroLift System (UL400) | Neotract, Inc. Dec 20, 2019 |
| K192383 — BriefCase | Aidoc Medical , Ltd. Dec 20, 2019 |
| K193235 — Telepack + | Karl Storz Endoscopy America, Inc. Dec 20, 2019 |
| K192711 — Dannik Titanium Ligation Clip | Dannik Dec 20, 2019 |
| K193238 — Nexus DR Digital X-Ray Imaging System (with vSharp) | Varex Imaging Corporation Dec 20, 2019 |
| K190284 — Bengal Stackable Cage System | Medos International SARL Dec 20, 2019 |
| K190008 — Carescape One | GE Healthcare Dec 20, 2019 |
| K183144 — uMC 560i | Shanghai United Imaging Healthcare Co., Ltd. Dec 19, 2019 |
| K192607 — LiteWalk | Viasonix , Ltd. Dec 19, 2019 |
| K193004 — Monopolar Cord | New Deantronics Taiwan , Ltd. Dec 19, 2019 |
| K192313 — Halo One Thin-Walled Guiding Sheath | C.R. Bard, Inc. Dec 19, 2019 |
| K191643 — TK Sterile Hypodermic Needle | Anhui Tiankang Medical Technology Co., Ltd. Dec 19, 2019 |
| K190935 — EZER, Portable X-ray System | Livermoretech, Inc. Dec 19, 2019 |
| K191305 — Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC Dec 19, 2019 |
| K182388 — Krystal Klear Aligners | Shatkin F.I.R.S.T., LLC Dec 19, 2019 |
| K192410 — ZS3 and z.one pro Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Dec 19, 2019 |
| K190775 — The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co. , Ltd. Dec 19, 2019 |
| K192229 — Neodent Implant System- GM Titanium Base for Bridge | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Dec 19, 2019 |
| K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. Dec 19, 2019 |
| K190881 — Spinal Elements Navigated Instruments | Spinal Elements, Inc. Dec 19, 2019 |
| K192589 — Everyway OTC TENS/EMS Combination | Everyway Medical Instruments Co.,Ltd Dec 19, 2019 |
| K192044 — 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. Dec 19, 2019 |
| K183676 — DentiqAir | 3D Industrial Imaging Co., Ltd. Dec 19, 2019 |
| K190829 — Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy Dec 19, 2019 |
| K193001 — Albumin BCP | SENTINEL CH. SpA Dec 19, 2019 |
| K192100 — Aveta Disposable Hysteroscope | Meditrina, Inc. Dec 19, 2019 |
| K190939 — ZOLL Arrhythmia Management Sysyem | Zoll Manufacturing Corporation Dec 19, 2019 |
| K191667 — Electronic Stethoscope | Hefei Mintti Medical Technology Co., Ltd. China Dec 18, 2019 |