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

FOZ 2025-05-02

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

Applicant Skydance Vascular, Inc.

K-Number K250292

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NHA 2025-05-01

Conical Ti Base abutments

Applicant BioHorizons Implant Systems, Inc.

K-Number K243521

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KCT 2025-05-01

ONE TRAY® Sealed Sterilization Container System

Applicant Innovative Sterilization Technologies

K-Number K250029

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HSN 2025-05-01

APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K-Number K250641

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MEH 2025-05-01

Resolve Modular Revision Hip Stem

Applicant United Orthopedic Corporation

K-Number K242315

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DXF 2025-05-01

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

Applicant Circa Scientific, Inc.

K-Number K251007

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OHS 2025-05-01

Wrinkle Treatment Device (JM1, JM2B)

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K244020

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QOF 2025-05-01

Xpert Xpress CoV-2/Flu/RSV plus

Applicant Cepheid®

K-Number K250995

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DQY 2025-05-01

APRO 45 Catheter

Applicant Alembic, LLC

K-Number K251014

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KDN 2025-05-01

X°Port Lung Preservation System; X°Port Lung Preservation Solution

Applicant Traferox Technologies, Inc.

K-Number K243870

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IYN 2025-05-01

Vscan Air

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K250087

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FDS 2025-05-01

Disposable Distal Attachment D-201 Series

Applicant Olympus Medical Systems Corp.

K-Number K250296

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