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

GBM 2025-03-05

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

Applicant Well Lead Medical Co., Ltd.

K-Number K241734

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QSZ 2025-03-05

NovoSorb® MTX

Applicant Polynovo Biomaterials Pty, Ltd.

K-Number K242149

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QDQ 2025-03-05

Prostate MR AI (VA10A)

Applicant Siemens Healthcare GmbH

K-Number K241770

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CGR 2025-03-05

Access Cortisol; DxC 500i Clinical Analyzer

Applicant Beckman Coulter, Inc.

K-Number K242190

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LZO 2025-03-04

Biolox® Delta Revision heads

Applicant Limacorporate

K-Number K243809

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KTI 2025-03-04

Disposable Cytology Brush (AF series)

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K-Number K241679

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NHA 2025-03-04

iPhysio® System

Applicant Euroteknika

K-Number K232383

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QIH 2025-03-04

Ceevra Reveal 3+

Applicant Ceevra, Inc.

K-Number K243933

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N/A 2025-03-04

Calibrate Interbody Systems

Applicant Alphatec Spine, Inc.

K-Number K243461

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OHS 2025-03-03

EnergyLounger (TY-01)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K241947

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JAQ 2025-03-03

Titanium Flexible Geometry FSD Applicator Set (GM11013400)

Applicant Varian Medical Systems, Inc.

K-Number K243939

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EOB 2025-03-03

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

Applicant Olympus Medical Systems Corporation

K-Number K243380

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