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

NHA 2025-10-23

DESS® Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K252384

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GEX 2025-10-23

MultiPulse TFL

Applicant Asclepion Laser Technologies GmbH

K-Number K253100

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OLR 2025-10-23

Silatrix Oral Gel

Applicant Sa3, LLC

K-Number K252425

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FAJ 2025-10-23

UV5000W Handle

Applicant Uroviu Corporation

K-Number K253226

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DYB 2025-10-23

PerQseal Introducers

Applicant Vivasure Medical Limited

K-Number K252309

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QIH 2025-10-23

TeraRecon Cardiovascular.Calcification.CT

Applicant Terarecon,Inc.

K-Number K250288

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QVF 2025-10-22

WELLlife COVID-19 Antigen Test Rx

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K251289

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JWH 2025-10-22

Freedom® Total Knee System – Titan PCK Components

Applicant Maxx Orthopedics, Inc.

K-Number K253144

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PCH 2025-10-22

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

Applicant QIAGEN GmbH

K-Number K252329

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MQV 2025-10-22

FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute

Applicant Prosidyan, Inc.

K-Number K253147

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LLZ 2025-10-22

Sirona Advanced Imaging Suite

Applicant Sirona Medical

K-Number K251030

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SCA 2025-10-22

Flowflex Plus RSV + Flu A/B + COVID Home Test

Applicant ACON Laboratories, Inc.

K-Number K251749

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