Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

KNS 2025-06-11

Rezum System

Applicant Boston Scientific Corporation

K-Number K250584

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QEW 2025-06-11

Liberant Thrombectomy System

Applicant Medtronic, Ireland

K-Number K250787

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BTR 2025-06-11

Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

Applicant William Cook Europe Aps

K-Number K251499

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HTY 2025-06-11

Impact PEEK Union Nail System

Applicant Nvision Biomedical Technologies

K-Number K250646

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SAH 2025-06-11

Self-Forming Magnet (Flexagon)

Applicant GI Windows, Inc.

K-Number K243482

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FAJ 2025-06-11

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)

Applicant Ambu A/S

K-Number K250269

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HQC 2025-06-11

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K242801

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KIF 2025-06-11

Injectable Root Canal Bioceramic Sealer (nRoot SP)

Applicant Enpuno Co., Ltd.

K-Number K250710

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NAY 2025-06-11

da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)

Applicant Intuitive Surgical, Inc.

K-Number K240852

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BTO 2025-06-10

5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

Applicant Vitaltec Corporation

K-Number K242921

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GEI 2025-06-10

EndyMed PRO MAX

Applicant Endymed Medical, Ltd.

K-Number K242996

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OWB 2025-06-10

EXTRON 3; EXTRON 5; EXTRON 7

Applicant DRTECH Corporation

K-Number K250010

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