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

FMF 2025-10-15

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K-Number K250510

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GEH 2025-10-15

TargetCool-e

Applicant Recensmedical, Inc.

K-Number K253348

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NZE 2025-10-15

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

Applicant Zoll Circulation, Inc.

K-Number K250979

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LLZ 2025-10-15

AGFA HealthCare Enterprise Imaging

Applicant Agfa Healthcare N.V.

K-Number K252199

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QZZ 2025-10-15

ELEOS™ Limb Salvage System with NanoCept® Technology

Applicant Onkos Surgical, Inc.

K-Number K252920

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MAI 2025-10-15

BioBrace® Extra-Articular Ligament Augmentation Kit

Applicant Conmed Corporation

K-Number K252946

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NEW 2025-10-15

V-soft Line™ Barbed Surgical Suture (Various)

Applicant Feeltech Co., Ltd.

K-Number K250107

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NKB 2025-10-14

PressON Spinal Fixation System

Applicant Nexus Spine

K-Number K253331

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MMK 2025-10-14

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

Applicant Pureway Compliance, Inc.

K-Number K251874

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MBI 2025-10-14

Mini Superhawk Suture Anchor System

Applicant Responsive Arthroscopy, LLC

K-Number K253010

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LHI 2025-10-14

FlowArt® Vial Access Device Vented

Applicant Asset Medikal

K-Number K251715

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GEX 2025-10-14

Lithoblast Single Use Holmium Laser Fibers

Applicant Dawell Medical, LLC

K-Number K250776

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