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

QAS 2024-05-15

Heuron ICH

Applicant Heuron Co., Ltd.

K-Number K233247

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SAX 2024-05-15

Notal Vision Home Optical Coherence Tomography (OCT) System

Applicant Notal Vision, Inc.

K-Number DEN230043

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HGX 2024-05-14

Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

Applicant Aoj Health Technology Co., Ltd.

K-Number K233913

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DQX 2024-05-14

BNLE Hydrophilic Jacketed Peripheral Guidewire

Applicant Biomerics Nle

K-Number K232662

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CAC 2024-05-14

Aventus Clot Management System

Applicant Inquis Medical

K-Number K240426

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JAK 2024-05-13

Brainomix 360 e-Lung

Applicant Brainomix Limited

K-Number K233875

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CBI 2024-05-13

Disposable Double Lumen Endobronchial Tube

Applicant Shenzhen Insighters Medical Technology Co., Ltd.

K-Number K232529

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EHD 2024-05-13

REMEX-GR100

Applicant Remedi Co., Ltd.

K-Number K240759

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LLZ 2024-05-13

MIM Monte Carlo Dosimetry

Applicant Mim Software, Inc.

K-Number K232862

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LZA 2024-05-13

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K232614

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PKT 2024-05-13

1060nm laser body slimming machine

Applicant Hebei JT Medical Co., Ltd.

K-Number K240658

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NGL 2024-05-13

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

Applicant Healgen Scientific,, LLC

K-Number K240949

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