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

HQC 2025-11-14

System Sophi

Applicant This AG

K-Number K250501

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SCA 2025-11-14

Status™ COVID-19/Flu A&B

Applicant Princeton BioMeditech Corp.

K-Number K251538

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HRS 2025-11-14

KLS Martin IPS Forearm System

Applicant KLS-Martin L.P.

K-Number K250865

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QIH 2025-11-14

AutoDensity

Applicant Eos Imaging

K-Number K251078

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CAF 2025-11-14

Mesh Nebulizer (H6)

Applicant Qingdao Future Medical Technology Co., Ltd.

K-Number K251659

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MYN 2025-11-14

Second Opinion® Panoramic

Applicant Pearl, Inc.

K-Number K250525

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LSR 2025-11-14

Lyme-ID IgG Test; Bio-ID800

Applicant Inanovate, Inc.

K-Number K252627

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IYN 2025-11-13

ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K253457

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OAS 2025-11-13

Dental Computed Tomography X-ray System

Applicant Fussen Technology Co., Ltd.

K-Number K251842

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HRS 2025-11-13

Geminus Volar Distal Radius Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K252949

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OHS 2025-11-13

LED Beauty Mask (RLBXX)

Applicant Atop Lighting Co., Ltd.

K-Number K252308

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SGO 2025-11-13

TELLTALE Electrosurgical Guidewire System

Applicant Telltale, LLC

K-Number K252592

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