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

NAY 2025-06-13

Vessel Sealer Curved (480522)

Applicant Intuitive Surgical, Inc.

K-Number K250674

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OVD 2025-06-12

OneLIF™ Interbody Fusion System

Applicant Novapproach Spine, LLC

K-Number K251459

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GEX 2025-06-12

Fractional CO2 Laser Machine

Applicant Zhengzhou PZ Laser Slim Technology Co., Ltd.

K-Number K250782

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JWY 2025-06-12

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

Applicant Biomérieux

K-Number K250856

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JTN 2025-06-12

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

Applicant Thermo Fisher Scientific (Oxoid Ltd.)

K-Number K250789

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EIH 2025-06-12

Multi M Series

Applicant Dmax Co., Ltd.

K-Number K250826

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JDS 2025-06-12

TRIGEN Stable Lock Nut & Washer

Applicant Smith & Nephew, Inc.

K-Number K243608

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GEX 2025-06-12

Q-Switched Nd:YAG Laser (SHE-LSP101-1)

Applicant Beijing Sano Laser S&T Development Co.,Ltd

K-Number K250936

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MQV 2025-06-12

Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft

Applicant Medtronic Sofamor Danek, Inc.

K-Number K251193

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BTG 2025-06-12

Disposable Cytology Brush BC-202D/203D Series

Applicant Olympus Medical Systems Corporation

K-Number K251279

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MYN 2025-06-12

Second Opinion® CS

Applicant Pearl, Inc.

K-Number K243234

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FTL 2025-06-12

Bard® Mesh; Bard® Mesh Pre-Shaped

Applicant Davol, Inc.

K-Number K251557

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