| K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260965 — CVAC Aspiration System | Calyxo, Inc. Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253357 — b-ONE® Bipolar Head | B-One Ortho, Corp. Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252280 — Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253861 — ACORYS MAPPING SYSTEM | Corify Care S.L Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254128 — InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252942 — ShaeferH | Shaeferh, LLC Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260508 — LOBO Vascular Occlusion System | Okami Medical, Inc. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252190 — DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252757 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253510 — Freestyle Mini Hands-free | Medela, LLC Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260090 — SMART Osteotomy System | Actis Medical Pty., Ltd. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260839 — Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254004 — VRNT | Cognifisense, Inc. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260244 — Auryon Atherectomy System | Eximo Medical Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253657 — Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | Covidien (Part of Medtronic) Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260082 — TRIOS Dx (R1) | 3Shape TRIOS A/S Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252241 — Pressio 3 Multi-parameter Neuromonitoring System | Sophysa Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253926 — Diacore | ShenB Co., Ltd. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | 1987 Media Limited Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253361 — Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253930 — Overjet Iris Intelligent Imaging System | Overjet, Inc. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252708 — Relu Cloud | Relu BV Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252699 — CoAptix S System | University of Utah, Department of Orthopaedics Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252207 — ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253689 — syngo Dynamics (VA41F) | Siemens Healthcare GmbH Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253917 — ARION ARC System | Plasma Surgical, Inc. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252548 — AI-Rad Companion Organs RT | Siemens Healthcare GmbH Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253777 — Ascblue (8010) | Ascblue Corporation Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253446 — AeroDR TX c02 | Dk Medical Systems Co., Ltd. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260430 — Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252250 — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. Fri Apr 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Anhui Happiness Workshop Instruments Co., Ltd. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260462 — RCT800 | Ray Co., Ltd. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254158 — SPINEART Navigation Instrument System | Spineart SA Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260245 — SILKBridge | KLISBio S.r.l. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254021 — Accuro XV | Rivanna Medical, Inc. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260555 — LOCATOR® Angled Abutment | Zest Anchors, LLC Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252251 — EASYMADE-TI | CG Bio Co., Ltd. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253975 — Radical 6F Access Catheter | Maduro Medical, Inc. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252228 — Seaman Pro/Seaman | Checkcells, Inc. Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260317 — Artelon Convenience Kits | International Life Sciences Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260067 — Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation Thu Apr 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Boston Scientific Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251889 — myAir | Resmed Corp Wed Apr 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |