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

MUD 2026-05-22

Spectrum-2

Applicant Neko Health AB

K-Number K254129

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LNH 2026-05-22

uMR Astra

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K260113

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QJP 2026-05-22

Zenith Distal Access Long Sheath

Applicant Suzhou Zenith Vascular SciTech Limited

K-Number K253359

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OLO 2026-05-22

Ion-C Navigation Instruments

Applicant SurGenTec, LLC

K-Number K260329

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DXC 2026-05-22

Arc Adjustable Radial Cuff Compression Device

Applicant Tz Medical, Inc.

K-Number K252772

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KGO 2026-05-22

Sterile Latex Powder Free Surgical Gloves

Applicant Protect Gloves Company Limited

K-Number K253060

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OIY 2026-05-22

DePuy ATTUNE™ Knee System

Applicant DePuy Orthopaedics, Inc.

K-Number K252887

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DQD 2026-05-22

AiSteth®

Applicant Ai Health Highway India Pvt., Ltd.

K-Number K252915

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OBP 2026-05-22

Apollo TMS Therapy System;Apollo light TMS Therapy System

Applicant Mag & More GmbH

K-Number K260560

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DQX 2026-05-22

InQwire Amplatz Guide Wire

Applicant Merit Medical Ireland, Ltd.

K-Number K254137

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OHV 2026-05-21

Ulthera® System

Applicant Ulthera, Inc.

K-Number K260618

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PKL 2026-05-21

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

Applicant Olympus Medical Systems Corp.

K-Number K260580

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