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

CHL 2025-05-02

i-STAT CG4+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K244014

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LLZ 2025-05-02

LUMYS (V1)

Applicant Intradys

K-Number K243069

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DSA 2025-05-02

SpO2 Extension Cable

Applicant Beijing Rongrui-Century Science & Technology Co., Ltd.

K-Number K242986

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FPA 2025-05-02

JetCan® Pro Safety Huber Needle

Applicant Pfm Medical, Inc.

K-Number K242763

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FGB 2025-05-02

F88 URE-SD/RD Flexible Ureteroscope

Applicant Sg Endoscopy Pte, Ltd.

K-Number K243894

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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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