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

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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LDP 2026-07-24

Atellica CH Acetaminophen 2 (ACTM)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K261364

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QIH 2026-07-24

DIANA

Applicant ROPCA ApS

K-Number K260192

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KRD 2026-07-24

OBSIDIO Conformable Embolic

Applicant Boston Scientific Corporation

K-Number K261488

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FCX 2026-07-24

VS-370CF, VS-370CT

Applicant VISION MEDICAL Co., Ltd.

K-Number K262152

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GCJ 2026-07-24

EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)

Applicant Medical Impact

K-Number K253541

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JAQ 2026-07-24

LumenCare Azure

Applicant Nucletron B.V.

K-Number K262383

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