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

LTT 2025-08-20

MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

Applicant Beckman Coulter, Inc.

K-Number K243804

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QIH 2025-08-20

Salix Coronary Plaque (V1.0.0)

Applicant Artrya Limited

K-Number K251837

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FGE 2025-08-20

EndoFix™Tissue Fixation System

Applicant Softac Medical Technologies

K-Number K251229

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NHA 2025-08-20

LOCATOR® Angled Abutment

Applicant Zest Anchors, LLC

K-Number K250721

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QSM 2025-08-19

Remanufactured EndoWrist Long Tip Forceps (420048)

Applicant Rebotix

K-Number K250387

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GEI 2025-08-19

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

Applicant Venclose, Inc.

K-Number K252316

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QSM 2025-08-19

Remanufactured EndoWrist Cadiere Forceps (420049)

Applicant Rebotix

K-Number K250399

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QSM 2025-08-19

Remanufactured EndoWrist Tenaculum Forceps (420207)

Applicant Rebotix

K-Number K250539

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MAI 2025-08-19

OSSIOfiber® Interference Screw

Applicant OSSIO , Ltd.

K-Number K252022

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GEI 2025-08-19

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Applicant Agnes Medical Co., Ltd.

K-Number K243713

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KGO 2025-08-19

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Applicant Harps Europe Manufacturing GmbH

K-Number K250313

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HRS 2025-08-18

ANTHEM® Fracture System

Applicant Globus Medical, Inc.

K-Number K251161

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