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

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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KNW 2025-09-24

Resitu Slider 09 (RESL09)

Applicant Resitu Medical AB

K-Number K252183

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FDF 2025-09-24

ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

Applicant Endorobotics Co., Ltd.

K-Number K244029

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OOE 2025-09-24

LenSx Laser System (8065000944)

Applicant Alcon Laboratories, Inc.

K-Number K252682

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MUH 2025-09-24

Digital X-Ray DentiMax Pro Imaging System

Applicant Dentimax, Inc.

K-Number K251206

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FGB 2025-09-24

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)

Applicant Boston Scientific Corporation

K-Number K252703

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QIH 2025-09-23

SwiftSight-Brain

Applicant Airs Medical, Inc.

K-Number K251483

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FAJ 2025-09-23

Zenflow Spring Scope

Applicant Zenflow, Inc.

K-Number K251140

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EOQ 2025-09-23

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K252045

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