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

QHA 2025-10-17

X1-FFR

Applicant Spectrawave, Inc.

K-Number K251355

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OLO 2025-10-17

StealthStation S8 Spine Software

Applicant Medtronic Navigation, Inc.

K-Number K251282

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OHS 2025-10-17

MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

Applicant Shenzhen Zhenxing Ruitong Technology Co., Ltd.

K-Number K252264

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ODC 2025-10-17

Biopsy Port Adapter

Applicant Endosound, Inc.

K-Number K250145

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SGG 2025-10-17

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

Applicant The Binding Site Group , Ltd.

K-Number K250159

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GEI 2025-10-16

Coolfase

Applicant Asterasys Co., Ltd.

K-Number K250852

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GCJ 2025-10-16

Arthrex Synergy Vision Imaging System

Applicant Arthrex, Inc.

K-Number K251994

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GAT 2025-10-16

ProZip Knotless Implant

Applicant Riverpoint Medical

K-Number K253024

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FMI 2025-10-16

Profoject™ Disposable Needle

Applicant CMT Health PTE., Ltd.

K-Number K252631

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FBK 2025-10-16

Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

Applicant Olympus Medical Systems Corporation

K-Number K252247

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QEW 2025-10-16

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K252612

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LLZ 2025-10-16

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Applicant Brainlab AG

K-Number K252476

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