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

QWB 2026-08-07

Metrix COVID Test; Metrix COVID Test Pro

Applicant Aptitude Medical Systems, Inc.

K-Number K253453

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QVR 2026-08-07

Xpert Hemorrhagic Fever

Applicant Cepheid

K-Number K261362

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PSY 2026-08-07

Aperio GT 450 DX; Aperio GT 180 DX

Applicant Leica Biosystems Imaging, Inc.

K-Number K253554

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FYA 2026-08-07

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

Applicant Yadu Medical (Henan) Co., Ltd.

K-Number K261028

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QKQ 2026-08-07

Aperio iQC DX Software

Applicant Leica Biosystems Imaging, Inc.

K-Number K253561

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FMI 2026-08-07

Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K260933

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OHS 2026-08-07

LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)

Applicant Shenzhen Chuangtong Yigou Technology Co., Ltd.

K-Number K261601

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EMA 2026-08-07

PacTemp Automix NE

Applicant The Belport Company Inc., DBA Gingi-Pak

K-Number K261937

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MAI 2026-08-07

Arthrex Bioabsorbable PushLock Suture Anchors

Applicant Arthrex, Inc.

K-Number K262357

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IYN 2026-08-07

Venue Go

Applicant GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

K-Number K261668

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JWH 2026-08-07

Freedom Total Knee System (E-Poly Tibial Liners)

Applicant Maxx Orthopedics, Inc.

K-Number K261563

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QNP 2026-08-07

EW10-EC02 Endoscopy Support Program

Applicant Fujifilm Corporation

K-Number K260567

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