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

NKB 2025-05-08

COLONNADE Posterior Screw Fixation System

Applicant CG Bio Co., Ltd.

K-Number K250582

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CBK 2025-05-08

AVEA disposable expiratory filter/water trap (11790)

Applicant Telesair, Inc.

K-Number K251133

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LRK 2025-05-08

Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue

Applicant Fissiontech, LLC

K-Number K250482

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NHA 2025-05-08

Preat Abutments

Applicant Preat Corporation

K-Number K243824

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IYN 2025-05-08

Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound

K-Number K242670

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OLO 2025-05-08

Altus Spine Navigation System

Applicant Altus Partners, LLC

K-Number K243419

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IYN 2025-05-08

Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)

Applicant Leltek, Inc.

K-Number K243226

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ITI 2025-05-08

eFOLDi Navigator Powerchair (STPC-A)

Applicant Suntech UK , Ltd.

K-Number K243110

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QIH 2025-05-08

Clarius Median Nerve AI

Applicant Clarius Mobile Health Corp.

K-Number K250226

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DZE 2025-05-08

OsseOne Dental Implant System

Applicant Synoross Dba Osseone

K-Number K233271

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KTT 2025-05-07

Extremity Medical External Fixation System

Applicant Extremity Medical, LLC

K-Number K251128

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MOB 2025-05-07

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)

Applicant Zeus Scientific

K-Number K243776

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