| K254099 — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Mar 27, 2026 |
| K254161 — Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Mar 27, 2026 |
| K260255 — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. Mar 27, 2026 |
| K251273 — Asurys Fluid Management System | Boston Scientific Corporation Mar 27, 2026 |
| K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Mar 27, 2026 |
| K252006 — OTTO Disinfecting Cap | Icu Medical, Inc. Mar 27, 2026 |
| K252295 — Ryurei | Terumo Corporation Mar 27, 2026 |
| K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. Mar 27, 2026 |
| K252081 — SportLinc Syndesmosis Device | Lincotek Medical Mar 27, 2026 |
| K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. Mar 27, 2026 |
| K260746 — S-scan Open (100001800) | Esaote, S.P.A. Mar 27, 2026 |
| K253270 — Contour ProtégéAI+ | Mim Software, Inc. Mar 27, 2026 |
| K260240 — SYMPHONY Navigation Ready Instruments | Medos International SARL Mar 27, 2026 |
| K254206 — Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. Mar 27, 2026 |
| K260697 — VyPlate Anterior Cervical Plate System | Vy Spine, LLC Mar 27, 2026 |
| K254239 — CyClean Cord | SS GLOBAL Mar 27, 2026 |
| K252893 — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo Mar 27, 2026 |
| K252148 — Butterfly Gestational Age Tool | Butterfly Network, Inc. Mar 27, 2026 |
| K253796 — Lunit INSIGHT DBT (V1.2) | Lunit, Inc. Mar 26, 2026 |
| K260273 — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. Mar 26, 2026 |
| K252926 — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | Restore Robotics Mar 26, 2026 |
| K253379 — Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. Mar 26, 2026 |
| K260601 — REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. Mar 26, 2026 |
| K260626 — Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. Mar 26, 2026 |
| K253627 — Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY Mar 26, 2026 |
| K253549 — DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC Mar 26, 2026 |
| K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX Mar 26, 2026 |
| K253775 — SwiftMR | Airs Medical, Inc. Mar 26, 2026 |
| K252037 — CUVIS-joint (CJ150) | Curexo, Inc. Mar 25, 2026 |
| K253680 — LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation Mar 25, 2026 |
| K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch And Lomb, Incorporated Mar 25, 2026 |
| K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | Medline Industries, LP Mar 25, 2026 |
| K252023 — MiraChlor Antimicrobial Wound Solution | Letus Corporation Mar 25, 2026 |
| K253615 — Invictus Bands System | Alphatec Spine, Inc. Mar 25, 2026 |
| K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. Mar 25, 2026 |
| K252432 — Flex-Z Cervical Cage | Spinepoint, LLC Mar 25, 2026 |
| K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. Mar 25, 2026 |
| K254278 — Arterial Pressure Monitoring Set/Tray | Spectrum Vascular Mar 25, 2026 |
| K260274 — Airlock® Ankle Plating System | Novastep SAS Mar 25, 2026 |
| K260291 — Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. Mar 25, 2026 |
| K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. Mar 25, 2026 |
| K254012 — Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd Mar 24, 2026 |
| K253198 — NanoKnife Generator (H78720300351US0) | Angiodynamics Mar 24, 2026 |
| K253047 — PRESSONE | Nipro Medical Corporation Mar 24, 2026 |
| K252169 — Access BNP II | Beckman Coulter, Inc. Mar 24, 2026 |
| K260787 — FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. Mar 24, 2026 |
| K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound And Primary Care Diagnostics Mar 24, 2026 |
| K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG Mar 24, 2026 |
| K252421 — JLK-NCCT | JLK, Inc. Mar 24, 2026 |
| K252099 — Trinias | Shimadzu Corporation Mar 24, 2026 |