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

FPA 2025-05-09

SteadiSet Infusion Set

Applicant Capillary Biomedical, LLC

K-Number K242692

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JAQ 2025-05-09

CT/ MR Tandem and Ovoid Set

Applicant Varian Medical Systems, Inc.

K-Number K250299

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IYN 2025-05-09

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Applicant Philips Ultrasound, LLC

K-Number K251110

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NVK 2025-05-08

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

Applicant Wuhan Pioon Technology Co., Ltd.

K-Number K243764

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JWH 2025-05-08

NextStep Arthropedix Total Knee System

Applicant Nextstep Arthropedix

K-Number K242410

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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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