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

QKQ 2025-06-26

AISight Dx

Applicant PathAI, Inc.

K-Number K243391

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KNG 2025-06-26

Doppler FHR Detector (BF-500D+, BF-560)

Applicant Shenzhen Bestman Instrument Co., Ltd.

K-Number K242846

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EZD 2025-06-26

Disposable Intermittent Catheter (TPU Catheter)

Applicant Chengdu Daxan Innovative Medical Tech. Co., Ltd.

K-Number K243175

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HRS 2025-06-26

Equinoxe® Scapula Fracture System

Applicant Exactech, Inc.

K-Number K243275

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IYO 2025-06-26

Velacur One (LI-1100)

Applicant Sonic Incytes Medical Corp

K-Number K251728

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DXN 2025-06-26

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)

Applicant Joytech Healthcare Co. , Ltd.

K-Number K250548

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FRG 2025-06-26

Sterilization Pouch and Roll

Applicant Yichang Xinxin Paper Products Co., Ltd.

K-Number K243179

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OHS 2025-06-25

CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K250966

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MAX 2025-06-25

X-PAC® LLIF Expandable Lateral Cage System

Applicant Expanding Innovations, Inc.

K-Number K251003

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GKZ 2025-06-25

Sysmex XR-Series (XR-10) Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K-Number K250943

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FGE 2025-06-25

EGIS Biliary Double Bare Stent (BDB080405)

Applicant S&G Biotech, Inc.

K-Number K242845

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NKG 2025-06-25

ANAX OCT Spinal System

Applicant Cg Medtech Co., Ltd.

K-Number K251725

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