Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

N/A 2026-06-15

VERAFEYE Imaging and Guidance System (VF-VIS-002)

Applicant Luma Vision Limited

K-Number K260885

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LXB 2026-06-15

Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

Applicant Zdeer Technology (Henan) Co., Ltd.

K-Number K260452

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GWQ 2026-06-13

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

Applicant Neuroelectrics Barcelona S.L.U.

K-Number K261604

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MWI 2026-06-12

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

Applicant Midmark Corporation

K-Number K253196

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IYE 2026-06-12

ThinkQA 3

Applicant Dosisoft SA

K-Number K252937

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PHX 2026-06-12

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

Applicant Stryker Corporation (Tornier, Inc.)

K-Number K260102

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OLU 2026-06-12

Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

Applicant VoxNeuro, Inc.

K-Number K253015

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ITI 2026-06-12

WHILL (WHILL Model C2)

Applicant Whill, Inc.

K-Number K261175

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QOF 2026-06-12

Fast PCR Mini Respiratory Panel

Applicant Autonomous Medical Devices Incorporated

K-Number K252932

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IMJ 2026-06-12

BTL-899TT

Applicant BTL Industries, Inc.

K-Number K252963

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NEW 2026-06-12

Barbed PDO Suture

Applicant Sutura Medical Technology, Inc.

K-Number K252171

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LHI 2026-06-12

ADRx™ Admixture Device

Applicant Epic Medical Pte. , Ltd.

K-Number K252987

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