| K231707 — ResQ Administration Set | Q For Plastic Industries Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232589 — Horos MD | Icat Solutions, Ltd. Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223397 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Hoya Lamphun , Ltd. Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233550 — MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic Tue Jan 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223714 — UniFit Dental Implant System | Adin Dental Implant Systems , Ltd. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230986 — Bladder Scanner | Avantsonic Technology Co., Ltd. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230438 — URIS Smart Path Implant System & Prosthetic | Truabutment, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233790 — ACL TOP 970 CL | Instrumentation Laboratory Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | Alcon Laboratories, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232688 — NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230006 — Ankyras | Mentice Spain S.L. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | Eco Medi Glove Sdn. Bhd. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230997 — EvoWalk 1.0 System | Evolution Devices, Inc. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230891 — SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Healthium Medtech Limited Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230985 — Planmeca Viso | Planmeca Oy Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233858 — TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231914 — Nurochek-II System | Headsafe Mfg Pty, Ltd. Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232756 — Colibrí | Copan Wasp Srl Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231084 — TearCare MGX System | Sight Sciences, Inc. Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232518 — EndoSound Vision System; EVS | Endosound, Inc. Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233300 — POWEReam 1/4 Drive | Stryker Instruments Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232937 — BTL-899M | BTL Industries, Inc. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231130 — TumorSight Viz | SimBioSys, Inc. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233659 — Suture Wing | Osteonic Co., Ltd. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233058 — VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231086 — CPM System | Analog Devices, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231794 — Elegant Advanced CompHort | Viramal Limited Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233264 — Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230439 — WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230267 — NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233109 — TP Pivot Pro Needle Guide | Civco Medical Solutions Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233082 — TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232789 — VIO System (V-1000) | Enspectra Health, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233304 — Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | Alicn Medical Shenzhen, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233742 — CloudTMS Edge for OCD | Teleemg, LLC Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230020 — BioTraceIO Lite | Techsomed Medical Technologies , Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233734 — Interson USB Ultrasound System | Interson Corporation Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232535 — MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223745 — Novae® Dual Mobility System, Hype® Hip System | Serf Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233027 — NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232300 — ElastiMed SACS | Elastimed , Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Jiangsu Kangbao Medical Equipment Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231805 — qXR-LN | Qure.Ai Technologies Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233104 — SofWave System | Sofwave Medical, Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |