Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GEI 2026-04-10

Ascblue (8010)

Applicant Ascblue Corporation

K-Number K253777

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QKB 2026-04-10

DeepBT Detector-Plus

Applicant Aitewan Biomedical Technology, Inc.

K-Number K252190

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HRS 2026-04-10

SMART Osteotomy System

Applicant Actis Medical Pty., Ltd.

K-Number K260090

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GDW 2026-04-10

Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads

Applicant Covidien (Part of Medtronic)

K-Number K253657

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HWC 2026-04-10

CoAptix S System

Applicant University of Utah, Department of Orthopaedics

K-Number K252699

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DQY 2026-04-10

Teleport Glide Microcatheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K253361

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OBR 2026-04-10

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

Applicant 1987 Media Limited

K-Number K252485

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GEI 2026-04-10

ARION ARC System

Applicant Plasma Surgical, Inc.

K-Number K253917

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OPP 2026-04-10

CeQur Simplicity On-Demand Insulin Delivery System

Applicant Cequr SA

K-Number K252757

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NGX 2026-04-10

Diacore

Applicant ShenB Co., Ltd.

K-Number K253926

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KRD 2026-04-10

LOBO Vascular Occlusion System

Applicant Okami Medical, Inc.

K-Number K260508

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JKA 2026-04-10

BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder

Applicant Becton, Dickinson and Company

K-Number K252506

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