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

DPS 2026-10-05

MyoVista wavECG (DG-200-B15-003)

Applicant HeartSciences, Inc.

K-Number K260005

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MUJ 2026-10-05

RT Elements (4.6)

Applicant Brainlab SE

K-Number K261655

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NDC 2026-10-05

Glucommander

Applicant Glytec, LLC

K-Number K261939

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IRP 2026-10-05

Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)

Applicant Sichuan Qianli-Beoka Medical Technology, Inc.

K-Number K262812

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LSE 2026-10-02

Elecsys EBV VCA IgG

Applicant Roche Diagnostics

K-Number K260232

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IYN 2026-10-02

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

Applicant GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

K-Number K261933

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HWC 2026-10-02

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

Applicant OsteoCentric Technologies

K-Number K263116

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HRS 2026-10-02

TDM Large Bone Plate and Screw System

Applicant Tdm Co., Ltd.

K-Number K261611

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LSE 2026-10-02

Elecsys EBV EBNA IgG

Applicant Roche Diagnostics

K-Number K260221

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QOF 2026-10-02

Xpert Xpress CoV-2/Flu plus

Applicant Cepheid®

K-Number K263120

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IZL 2026-10-02

REMEX-T(K)100C

Applicant Remedi, Inc.

K-Number K261943

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QJU 2026-10-02

Lung Guidance

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K261042

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