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

NKB 2025-04-28

Eminent Spine 3D Titanium Pedicle Screw System

Applicant Eminent Spine

K-Number K241663

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NEW 2025-04-28

Suture-TOOL System

Applicant Suturion AB

K-Number K250977

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OWB 2025-04-28

uAngio AVIVA CX

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K243376

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IYN 2025-04-28

Flash Ultrasound System 5100 Point of Care

Applicant Philips Ultrasound, LLC

K-Number K250030

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BTA 2025-04-26

AIRO Suction Unit (AIRO-01)

Applicant Cro, LLC

K-Number K251101

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OVE 2025-04-25

Cervical Spine Truss System (CSTS)

Applicant 4Web Medical

K-Number K251117

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OUR 2025-04-25

DYNAMIS™ Implant System

Applicant Promethean Restorative, LLC

K-Number K251075

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QOF 2025-04-25

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

Applicant Roche Molecular Systems, Inc.

K-Number K243400

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HRS 2025-04-25

CastleLoc Pectus Bar System

Applicant L&K BIOMED Co., Ltd.

K-Number K250892

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FLL 2025-04-25

Infrared Thermometer

Applicant Guangzhou Daxin Health Technology Co., Ltd.

K-Number K243082

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FRG 2025-04-25

Self Sealing Sterilization Pouches

Applicant Wellmed Dental Medical Supply Co., Ltd.

K-Number K243721

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KDN 2025-04-25

DCX Disposable Cassette (DCX)

Applicant Institut Geroges Lopez

K-Number K243998

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