PMN records

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.2026-07-31
K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.2026-07-31
K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.2026-07-31
K261912SnØreNegatØrDnB Innovations, LLC2026-07-31
K261854xvision Spine systemAugmedics, Ltd.2026-07-31
K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.2026-07-31
K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group2026-07-31
K261809Interwedge® Standalone LateralFoundation Surgical Group2026-07-31
K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.2026-07-31
K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC2026-07-31
K261451ZSAlign Cervical Interbody SystemZSFab, Inc.2026-07-31
K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.2026-07-31
K261331I-Genius (100019400)Esaote, S.p.A.2026-07-31
K261187Hearing Aid FeatureSamsung Electronics Co., Ltd.2026-07-31
K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation2026-07-31
K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)2026-07-31
K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG2026-07-31
K260607Shield System (Siemens 30x40)Radiaction , Ltd.2026-07-31
K254042WatchPAT SWItamar Medical , Ltd.2026-07-31
K253835AffinityHermes Medical Solutions AB2026-07-31
K2538000909FCE, 0909FCE-HSRayence Co., Ltd.2026-07-31
K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbH2026-07-31
K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical2026-07-31
K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.2026-07-31
K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy2026-07-30
K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.2026-07-30
K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.2026-07-30
K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics2026-07-30
K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC2026-07-30
K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre2026-07-30
K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs2026-07-30
K261288Handheld Ultrasound ScannerIMGFAX CO., LTD.2026-07-30
K260980cmAngio® V2.0Curemetrix, Inc.2026-07-30
K260624Arthrex Radial Head Replacement SystemArthrex, Inc.2026-07-30
K260620SeptAlign (SPLN001)Spirair, Inc.2026-07-30
K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.2026-07-30
K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.2026-07-30
K254038Motivista (CT-155)Click Therapeutics, Inc.2026-07-30
K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.2026-07-30
K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.2026-07-30