Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NXC 2025-10-23

Invisalign® Palatal Expander System

Applicant Align Technology, Inc.

K-Number K252931

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GEX 2025-10-23

Picosecond Laser Device (PF131-BI)

Applicant Risu Medical Technology Co., Ltd.

K-Number K252345

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LZA 2025-10-23

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K250861

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GEX 2025-10-23

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)

Applicant Zhengzhou PZ Laser Slim Technology Co., Ltd.

K-Number K252732

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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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