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

MUD 2024-03-01

OxiplexTS200

Applicant Iss Medical, Inc.

K-Number K232385

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QOF 2024-03-01

LIAISON PLEX Respiratory Flex Assay

Applicant Luminex Corporation

K-Number K233410

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NUH 2024-03-01

S21 OTC Transcutaneous Electrical Nerve Stimulator

Applicant Micro Current Technology, Inc.

K-Number K233095

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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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