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

ITI 2024-08-09

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)

Applicant Suzhou Ideal Medical Co., Ltd.

K-Number K240079

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CBP 2024-08-09

F&P Optiflow Flow Diverter

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K234053

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IYN 2024-08-09

SonoMax Series Digital Color Doppler Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K233697

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MNT 2024-08-09

F&P Airvo 3 NIV (PT311US)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K233643

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KNW 2024-08-09

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

Applicant SurGenTec, LLC

K-Number K240664

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GEX 2024-08-09

MEDIDIODE

Applicant Medicreations, LLC

K-Number K231950

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EKX 2024-08-09

The Trust

Applicant Genoss Co., Ltd.

K-Number K222688

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JZO 2024-08-09

Access TPO Antibody

Applicant Beckman Coulter, Inc.

K-Number K240469

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GAT 2024-08-09

HyperSuture All Blue Extension Line

Applicant Threadstone, LLC

K-Number K241376

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BTT 2024-08-08

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K234058

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LLZ 2024-08-08

SynthVISION 1.0.0

Applicant Synthesis Health Intelligence, Inc.

K-Number K240724

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ELC 2024-08-08

OdneClean

Applicant Odne AG

K-Number K233844

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