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

OWB 2025-07-22

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

Applicant Brainlab AG

K-Number K243432

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SFG 2025-07-22

LymphaTech Mobile 3D Measuring Tool

Applicant Lymphatech, Inc.

K-Number K251255

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DXR 2025-07-22

CardioTag™

Applicant Cardiosense, Inc.

K-Number K243566

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KNW 2025-07-22

Disposable Biopsy Needle

Applicant Zhejiang Curaway Medical Technology Co., Ltd.

K-Number K244018

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JXI 2025-07-22

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)

Applicant Alafair Biosciences

K-Number K251505

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GJS 2025-07-21

microINR System

Applicant Iline Microsystems, S.L.

K-Number K251564

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OBJ 2025-07-19

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

Applicant Jiangsu Tingsn Technology Co., Ltd.

K-Number K250913

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HRS 2025-07-18

Baby Gorilla®/Gorilla® Plating System

Applicant Paragon 28, Inc.

K-Number K250952

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HIH 2025-07-18

SPY Cystoscope/Hysteroscope

Applicant Stryker Endoscopy

K-Number K252012

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ODG 2025-07-18

InstaFAN

Applicant Onepass Medical , Ltd.

K-Number K251542

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OWW 2025-07-18

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)

Applicant Alafair Biosciences

K-Number K251655

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LHI 2025-07-18

HyHub™ and HyHub™ Duo Vial Access Devices

Applicant Takeda Pharmaceuticals

K-Number K243404

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