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

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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HAW 2025-09-04

Ball Joint Guide Array (66295)

Applicant Bayer Medical Care, Inc.

K-Number K250893

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OBP 2025-09-04

Apollo TMS Therapy System

Applicant Mag & More GmbH

K-Number K243700

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OHS 2025-09-04

KALA MINI 2.0 (KALA-04)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K251781

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SBF 2025-09-04

NextAR(TM) Shoulder Platform

Applicant Medacta International S.A.

K-Number K251737

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NFO 2025-09-03

NeurotriS (SX2500); NeurotriS (SX3800)

Applicant A-1 Engineering

K-Number K251909

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GEI 2025-09-03

AGNES Ultra

Applicant Agnes Medical Co., Ltd.

K-Number K250217

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