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

LNH 2024-04-12

OASIS MRI System

Applicant Fujifilm Healthcare Corporation

K-Number K240571

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EIH 2024-04-12

UltraThineer Zirconia Slurry (5Y-B)

Applicant Boston Micro Fabrication

K-Number K240419

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JSM 2024-04-11

Azer Scientific Universal Transport Medium

Applicant Azer Scientific, Inc.

K-Number K202531

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JAK 2024-04-11

True Enhance DL

Applicant Ge Healthcare Japan Corporation

K-Number K233698

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DZE 2024-04-11

Ni2 Implant System

Applicant Newton Implant Systems, Inc.

K-Number K221847

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MBI 2024-04-11

OC JuggerKnot Soft Anchor

Applicant Riverpoint Medical

K-Number K240719

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ESD 2024-04-11

Lyric4 Hearing Aid

Applicant Sonova AG

K-Number K232999

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OUR 2024-04-11

TiLink-P SI Joint Fusion System

Applicant SurGenTec, LLC

K-Number K240720

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GEX 2024-04-11

TitanPico Laser Workstation (PICO-450)

Applicant Rhein Laser Technologies Co., Ltd.

K-Number K233757

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OBO 2024-04-10

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))

Applicant Topcon Corporation

K-Number K233561

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NGX 2024-04-10

Electromagnetic Stimulation Systems

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K232409

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CAF 2024-04-10

Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%

Applicant Mankind Pharma Limited

K-Number K232523

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