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

OLO 2026-07-24

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K261024

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IYO 2026-07-24

Accuro 3S

Applicant Rivanna Medical, Inc.

K-Number K253452

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OWN 2026-07-24

PerfusiX-Imaging

Applicant LIMIS Development B.V.

K-Number K254180

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QIH 2026-07-24

SwiftMR

Applicant Airs Medical, Inc.

K-Number K261349

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IOR 2026-07-24

GEN 4 JOY Wheelchair

Applicant Free Wheelchair Mission

K-Number K252370

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MLP 2026-07-24

Temporary Keratoprosthesis (QuickSet TKP™)

Applicant Eyekon Medical, Inc.

K-Number K261312

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DHB 2026-07-24

NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut

Applicant Hycor Biomedical

K-Number K261027

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MOS 2026-07-24

dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T

Applicant Philips Medical Systems Nederland B.V.

K-Number K262294

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FRN 2026-07-24

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

Applicant Deka R&D Corp

K-Number K253703

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OHS 2026-07-24

5 Wavelength LED Facemask (TN2508)

Applicant iSMART Developments, Ltd.

K-Number K260598

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JTN 2026-07-24

Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60

Applicant Thermo Fisher Scientific (Oxoid Ltd.)

K-Number K261781

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NKB 2026-07-24

Tiger 2 System

Applicant Zavation Medical Products, LLC

K-Number K253943

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