| K254207 — AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. Mon Mar 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260812 — Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention Mon Mar 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260037 — implantcast Packaging System Update | Implantcast GmbH Mon Mar 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252360 — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. Sat Mar 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260257 — CO2 Laser System | Sanhe Meditech Co., Ltd. Sat Mar 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253307 — Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253649 — Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253392 — Synergy Disc Instruments | Synergy Spine Solutions, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251273 — Asurys Fluid Management System | Boston Scientific Corporation Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260294 — SF Push-in Anchor | Surgical Fusion Technologies GmbH Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253980 — Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260255 — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252195 — ARTICOR planner | Artiness S.R.L Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254161 — Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260041 — MDx-Chex for BCP | Streck, LLC Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252064 — MedCAD® AccuStride System | Medcad Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252006 — OTTO Disinfecting Cap | Icu Medical, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252295 — Ryurei | Terumo Corporation Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252081 — SportLinc Syndesmosis Device | Lincotek Medical Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260746 — S-scan Open (100001800) | Esaote, S.p.A. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253270 — Contour ProtégéAI+ | Mim Software, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260240 — SYMPHONY Navigation Ready Instruments | Medos International SARL Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254206 — Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260697 — VyPlate Anterior Cervical Plate System | Vy Spine, LLC Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254239 — CyClean Cord | SS GLOBAL Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252893 — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252148 — Butterfly Gestational Age Tool | Butterfly Network, Inc. Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253796 — Lunit INSIGHT DBT (V1.2) | Lunit, Inc. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253379 — Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252926 — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | Restore Robotics Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260601 — REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260626 — Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253549 — DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253775 — SwiftMR | Airs Medical, Inc. Thu Mar 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253680 — LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253615 — Invictus Bands System | Alphatec Spine, Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252037 — CUVIS-joint (CJ150) | Curexo, Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252023 — MiraChlor Antimicrobial Wound Solution | Letus Corporation Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |