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

OHS 2025-06-20

LED LIGHT MASK (A093)

Applicant Foshan Guangyu Weilai Medical Equipment Co., Ltd.

K-Number K250880

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EMA 2025-06-20

EsCem RMGI

Applicant Spident Co., Ltd.

K-Number K250566

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JXG 2025-06-20

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

Applicant Sophysa

K-Number K242974

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DPW 2025-06-20

FloPatch FP120

Applicant Flosonics Medical

K-Number K251114

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JAK 2025-06-20

CT Scanner TSX-501R/1 V11.1

Applicant Canon Medical Systems Corporation

K-Number K243398

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ODC 2025-06-20

Disposable Endoscopy Valve Set

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K250732

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SDJ 2025-06-20

Us2.ca

Applicant Eko.Ai Pte Ltd. D/B/A Us2.Ai

K-Number K250151

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KGN 2025-06-20

CollOvine Wound Dressing

Applicant Ovigenex, LLC

K-Number K242985

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GEI 2025-06-20

HybridAPC probe

Applicant Erbe Elektromedizin GmbH

K-Number K243120

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KCT 2025-06-20

PAL Sterilization Case

Applicant Microaire Surgical Instruments, LLC

K-Number K243589

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PDJ 2025-06-20

Medconn Glycated Hemoglobin Test system

Applicant Shanghai Medconn Medical Technology Co., Ltd.

K-Number K242911

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PHC 2025-06-20

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)

Applicant Becton Dickinson

K-Number K243062

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