Latest 510(k) clearances
Newest first, 50 per page. Open a clearance to see any recalls that name it.
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2026 | K260338 | ThinkSono Guidance ThinkSono GmbH, DE | QJU |
| Jul 15, 2026 | K260206 | SkeletonPlanner UPlanner B.V. - Presurgeo, NL | QIH |
| Jul 15, 2026 | K260050 | WRAP System Huneo, LLC | MNR |
| Jul 15, 2026 | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system Hamamatsu Photonics K.K., JP | PSY |
| Jul 15, 2026 | K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant Atlas Spine, Inc. | PLR |
| Jul 14, 2026 | K261633 | VisuBreath Affirm Medical Technologies II, LLC | CCK |
| Jul 14, 2026 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Jul 14, 2026 | K261249 | Universal Seal (5-12 mm) Intuitive Surgical, Inc. | GCJ |
| Jul 14, 2026 | K261232 | IERO Mobility Scooter (IERO-01) Jochu Technology Co., Ltd., TW | INI |
| Jul 14, 2026 | K261020 | Symmetrix L Spinal System Medtronic Sofamor Danek USA, Inc. | MAX |
| Jul 14, 2026 | K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set Ambu A/S, DK | GXY |
| Jul 14, 2026 | K253667 | Accoat Guide Wire Sp Medical A/S, DK | DQX |
| Jul 14, 2026 | K253662 | LIXI (LXOSFM1) Luwi, LLC | MSC |
| Jul 13, 2026 | K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire Merit Medical Ireland , Ltd., IE | DQX |
| Jul 13, 2026 | K261199 | Wearable Breast Pump (Model S32A) Shenzhen TPH Technology Co., Ltd., CN | HGX |
| Jul 13, 2026 | K261085 | Rapid Vessel Occlusion (Rapid VO) iSchemaview | QAS |
| Jul 13, 2026 | K260208 | Ultra-Fine SAFETY Insulin Syringe embecta Medical II, LLC | FMF |
| Jul 13, 2026 | K260199 | SLIM Microcatheter Balt USA, LLC | QJP |
| Jul 13, 2026 | K254044 | Hearing assist Meta Platform Technologies, LLC | SCR |
| Jul 13, 2026 | K253504 | Volnewmer Classys, Inc., KR | GEI |
| Jul 10, 2026 | K262120 | Avara Viewer Avara Software | LLZ |
| Jul 10, 2026 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System Boston Scientific Corporation | ESW |
| Jul 10, 2026 | K261949 | NYES Tuff Cuff L3 Disposable Gowns New York Embroidery Studio | FYA |
| Jul 10, 2026 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Jul 10, 2026 | K261306 | AI Contouring (VA10A) Varian Medical Systems | QKB |
| Jul 10, 2026 | K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test ACON Laboratories, Inc. | SCA |
| Jul 10, 2026 | K261149 | Electric Wheelchair (DY611A-2, DY612A-1) Zhejiang Lumbre Electric Appliance Co., Ltd., CN | ITI |
| Jul 10, 2026 | K261041 | ClearSafe Closed System MedSource Labs, LLC | FOZ |
| Jul 10, 2026 | K261031 | POSEIDON ST Signus Medinzintechnik GmbH, DE | MQP |
| Jul 10, 2026 | K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+ Cochlear Americas | PFO |
| Jul 10, 2026 | K260880 | SedLine Sedation Monitor Masimo Corporation | OLW |
| Jul 10, 2026 | K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | LSR |
| Jul 10, 2026 | K254037 | LungFlow Airway Catheter Free Flow Medical, Inc. | EOQ |
| Jul 10, 2026 | K253670 | SmartCT (R3.0 (L10)) Philips Medical Systems B.V., NL | OWB |
| Jul 10, 2026 | K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 Fr C.R. Bard, Inc. | KNT |
| Jul 10, 2026 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian Capenergy Medical S.L., ES | PBX |
| Jul 9, 2026 | K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture Teleflex Medical, LLC | NEW |
| Jul 9, 2026 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS Smith & Nephew, Inc. | MBI |
| Jul 9, 2026 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology Medtronic MiniMed | QJI |
| Jul 9, 2026 | K261569 | UbiqVue 2AYe Cardiac System (UX2253) Lifesignals, Inc. | DRG |
| Jul 9, 2026 | K261471 | Zeta TMS Navigation System Zeta Surgical, Inc. | QFF |
| Jul 9, 2026 | K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer PINKSLIP, LLC | NUC |
| Jul 9, 2026 | K261166 | DIA-CEM DiaDent Group International, KR | EMA |
| Jul 9, 2026 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) Procept Biorobotics | PZP |
| Jul 9, 2026 | K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter MedSource Labs, LLC | FOZ |
| Jul 9, 2026 | K260157 | LifeLens Physiological Monitor LifeLens Technologies, Inc. | DSH |
| Jul 9, 2026 | K253901 | Millipede88 Access Catheter Perfuze, Ltd., IE | QJP |
| Jul 9, 2026 | K253899 | 3D-Anywhere Provect.AI | LLZ |
| Jul 9, 2026 | K252978 | ScioCardio ECG Analysis Platform Synergen Technology Labs, LLC | DQK |
| Jul 8, 2026 | K262300 | Denture Base Resin V2 Formlabs Ohio, Inc. | EBI |