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

QIH 2025-09-25

Brain WMH

Applicant Quantib B.V.

K-Number K251527

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PCH 2025-09-25

Panther Fusion GI Expanded Bacterial Assay

Applicant Hologic, Inc.

K-Number K251993

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OCX 2025-09-25

Single-Use Biopsy Valve (MAJ-1555)

Applicant Olympus Medical Systems Corporation

K-Number K251997

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GEX 2025-09-25

Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)

Applicant Wuhan Dimed Laser Technology Co., Ltd.

K-Number K252063

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MZP 2025-09-25

Alinity m HCV

Applicant Abbott Molecular, Inc.

K-Number K252102

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JWH 2025-09-25

Stem Extension Line (U2 Total Knee SystemPSA Type)

Applicant United Orthopedic Corporation

K-Number K252725

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QUR 2025-09-25

Essilor® Stellest®

Applicant Essilor Of America, Inc.

K-Number DEN250016

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DQK 2025-09-25

EnSite X EP System

Applicant ABBOTT MEDICAL

K-Number K252013

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GEX 2025-09-24

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

Applicant Alma Lasers, Inc.

K-Number K250071

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MVL 2025-09-24

Retraxil

Applicant Kulzer, LLC

K-Number K243910

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QFG 2025-09-24

t:slim X2 insulin pump with interoperable technology

Applicant Tandem Diabetes Care, Inc.

K-Number K250792

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FRC 2025-09-24

Celerity 20 HP Biological Indicator

Applicant STERIS Corporation

K-Number K252680

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