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

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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HET 2025-04-25

i-Cut

Applicant A.M.I. Agency For Medical Innovations GmbH

K-Number K243821

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FRN 2025-04-25

BD Alaris Infusion System with Guardrails Suite MX

Applicant Carefusion 303, Inc.

K-Number K243855

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MCW 2025-04-25

FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

Applicant Cardio Flow Inc.,

K-Number K250723

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JAQ 2025-04-25

Intracavitary/Interstitial System

Applicant Varian Medical Systems

K-Number K250289

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JOJ 2025-04-25

VERIFY STEAM Integrating Indicator

Applicant STERIS Corporation

K-Number K243876

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