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

QOF 2025-05-01

Xpert Xpress CoV-2/Flu/RSV plus

Applicant Cepheid®

K-Number K250995

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DQY 2025-05-01

APRO 45 Catheter

Applicant Alembic, LLC

K-Number K251014

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KDN 2025-05-01

X°Port Lung Preservation System; X°Port Lung Preservation Solution

Applicant Traferox Technologies, Inc.

K-Number K243870

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IYN 2025-05-01

Vscan Air

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K250087

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FDS 2025-05-01

Disposable Distal Attachment D-201 Series

Applicant Olympus Medical Systems Corp.

K-Number K250296

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QOF 2025-05-01

Xpert Xpress CoV-2/Flu/RSV plus

Applicant Cepheid®

K-Number K250996

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JWY 2025-04-30

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

Applicant Biomerieux S.A.

K-Number K250274

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HKI 2025-04-30

Resolve Fundus Camera

Applicant Optain Health, Inc.

K-Number K250683

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EOQ 2025-04-30

LumiRex Bronchoscope

Applicant Contra Healthcare Solutions, LLC

K-Number K243541

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JKA 2025-04-30

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

Applicant Sol-Millennium Medical, Inc.

K-Number K250907

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EBF 2025-04-30

Additive Manufacturing (Light Curing) Crown Bridge Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K250497

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NHA 2025-04-30

Dentsply Sirona Titanium Bases system

Applicant Dentsply Sirona

K-Number K250295

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