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

KNT 2026-09-30

danumed StomaMeter

Applicant Danumed Medizintechnik GmbH

K-Number K262038

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OHT 2026-09-30

Braun Aura 7 (6041)

Applicant CyDen Limited

K-Number K261975

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OAS 2026-09-30

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)

Applicant Fussen Technology Co., Ltd.

K-Number K263033

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QYE 2026-09-30

ECG Analysis Software (AiTiALVSD)

Applicant Medical AI Co., Ltd.

K-Number K254302

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NKB 2026-09-30

Duet™ Spinal Fixation System

Applicant Duet Spine Holdings, LLC

K-Number K262712

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OZE 2026-09-30

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)

Applicant Centers for Disease Control and Prevention

K-Number K263035

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GAM 2026-09-29

Fast Absorbing PGLA

Applicant Riverpoint Medical, LLC

K-Number K263073

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MQC 2026-09-29

THERMEO® I MSI

Applicant Pro3Dure Medical GmbH

K-Number K260031

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ITI 2026-09-29

Electric Wheelchair (0080)

Applicant Xuzhou Heabens Medical Technology Co., Ltd.

K-Number K262241

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OVE 2026-09-29

NeckTune™ SA Cervical Cage

Applicant Medyssey Co., Ltd.

K-Number K262726

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DPS 2026-09-29

QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)

Applicant QT Medical, Inc.

K-Number K260250

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INI 2026-09-29

Power Mobility Scooter (MA03)

Applicant Nanjing Mijo Technology Co., Ltd.

K-Number K262213

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