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

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 System—PSA Type)

Applicant United Orthopedic Corporation

K-Number K252725

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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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DYB 2025-09-24

Pounce(TM) Sheath

Applicant Surmodics,Inc.

K-Number K252227

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IZQ 2025-09-24

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Applicant Imaxeon Pty, Ltd.

K-Number K252689

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FET 2025-09-24

ProVee Video Processing Unit (PV-003)

Applicant Proverum Limited

K-Number K251734

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LLZ 2025-09-24

uWS-Angio Pro

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K250045

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