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

CAW 2025-12-22

Oxygen Concentrator-P2-O5E

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K-Number K251764

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GEX 2025-12-19

JOULE 1064nm System and Accessories

Applicant Sciton, Inc

K-Number K251077

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NUC 2025-12-19

Chiavaye Personal Moisturizer

Applicant Unipack, LLC

K-Number K251011

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NQQ 2025-12-19

LIA Console (542-7)

Applicant Leadoptik, Inc.

K-Number K251730

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GEX 2025-12-19

CO2 Laser Therapy System (Model: LFS-D9U)

Applicant Sanhe Lefis Electronics Co., Ltd.

K-Number K250998

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QIH 2025-12-19

AI-CVD

Applicant HeartLung Corporation

K-Number K252029

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DQA 2025-12-19

Spo2 Sensor CSS032D

Applicant Shenzhen Ykd Technology Co., Ltd.

K-Number K251751

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OHS 2025-12-19

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

Applicant Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.

K-Number K253054

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GEX 2025-12-19

SANDRO Dual

Applicant Wontech Co., Ltd.

K-Number K252877

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DQD 2025-12-19

eMurmur Heart AI

Applicant Csd Labs

K-Number K252284

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BTT 2025-12-19

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K253479

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HGX 2025-12-19

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K-Number K252342

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