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

HKI 2025-09-04

Optina-4C (MHRC-C1N)

Applicant Optina Diagnostics, Inc.

K-Number K250770

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QIH 2025-09-04

Careverse CoronaryDoc (Careverse CoronaryDoc)

Applicant Careverse Technology Pte. , Ltd.

K-Number K251656

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MAX 2025-09-04

Endoskeleton™ Interbody Systems

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K251444

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SAQ 2025-09-04

Symani Surgical System

Applicant Medical Microinstruments, Inc.

K-Number K251510

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MUJ 2025-09-04

Dose+ (1.0)

Applicant Mvision AI OY

K-Number K250064

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DQK 2025-09-04

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

Applicant ABBOTT MEDICAL

K-Number K251463

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DXX 2025-09-04

LIBERTY Endovascular Robotic System (LIBERTYOS)

Applicant Microbot Medical , Ltd.

K-Number K243789

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ONF 2025-09-04

Intense Pulsed Light Therapy Device (MMABM-1)

Applicant Micowey Medical Equipment (Guangxi) Co., Ltd.

K-Number K251545

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EHD 2025-09-04

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K251438

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LRK 2025-09-04

Oniris; Oniris Plus

Applicant Oniris

K-Number K250353

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LGZ 2025-09-04

Fluido® AirGuard System

Applicant The Surgical Company International BV (As Tsc Life)

K-Number K251733

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LLZ 2025-09-04

Image Suite

Applicant Carestream Health, Inc.

K-Number K251168

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