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

QIH 2025-08-07

UNiD™ Spine Analyzer

Applicant Medicrea International S.A.S. (Medtronic)

K-Number K251629

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OHS 2025-08-07

LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)

Applicant Shenzhen Liyoutong Technology Co., Ltd.

K-Number K251667

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QEB 2025-08-07

LuMon(TM) System

Applicant Sentec AG

K-Number K243765

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HSB 2025-08-07

Succession™ AFN System

Applicant Ortho Solutions UK , Ltd.

K-Number K250622

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QPL 2025-08-07

BTL-199

Applicant BTL Industries, Inc.

K-Number K250309

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LZO 2025-08-07

Longboard Revision Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K243021

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KWL 2025-08-06

InterSpace GV Hip Spacer

Applicant Tecres S.P.A.

K-Number K252326

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GEX 2025-08-06

Olo

Applicant El.En S.P.A.

K-Number K251432

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MBI 2025-08-06

Aevumed PHANTOM Suture Anchors

Applicant Aevumed, Inc.

K-Number K242895

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FPA 2025-08-06

SteadiSet infusion set

Applicant Tandem Diabetes Care

K-Number K251854

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JXG 2025-08-06

Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)

Applicant Integra Lifesciences Production Corporation

K-Number K243552

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LNH 2025-08-06

InVision™ 3T Recharge Operating Suite

Applicant Imris Imaging, Inc.

K-Number K252239

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