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

QIH 2024-03-01

BoneMRI

Applicant Mriguidance B.V.

K-Number K233030

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CBK 2024-03-01

Nihon Kohden NKV-550 Series Ventilator System

Applicant Nihon Kohden Orangemed, LLC

K-Number K231778

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KGN 2024-03-01

MiroDry Wound Matrix

Applicant Reprise Biomedical, Inc.

K-Number K240277

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NUH 2024-03-01

Muscle Stimulator

Applicant Shenzhen Yiran Intelligent Co., Ltd.

K-Number K231648

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DSY 2024-03-01

GORE® PROPATEN® Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K-Number K240083

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NUC 2024-03-01

Gynatrof

Applicant Tyros Biopharma, Inc.

K-Number K232040

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FLL 2024-03-01

Probe Covers (YF-001, YF-002)

Applicant Shenzhen YI Fang Blister Packaging Co., Ltd.

K-Number K240023

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FPA 2024-03-01

Insignis™ Syringe Infusion System

Applicant Innovative Health Sciences, LLC

K-Number K232328

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QIH 2024-02-29

inHEART Models

Applicant Inheart, Sas

K-Number K231683

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NDN 2024-02-29

Balloon Inflation System

Applicant Ningbo Hicren Biotechnology Co., Ltd.

K-Number K232842

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KWQ 2024-02-29

Curiteva Thoracolumbar Plate System

Applicant Curiteva, Inc.

K-Number K233360

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DTK 2024-02-29

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

Applicant Bd

K-Number K240257

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