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 2025-09-26

Thulium Laser System (Deluxlase)

Applicant Nanjing Bestview Laser S&T Co., Ltd.

K-Number K251919

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EZD 2025-09-26

LoFric Origo

Applicant Wellspect AB

K-Number K250659

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BWH 2025-09-26

Radial Jaw 4 Pulmonary Biopsy Forceps

Applicant Boston Scientific Corporation

K-Number K252921

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DZE 2025-09-26

S.I.N. Dental Implant System

Applicant S.I.N. Implant System Ltda

K-Number K251262

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FDA 2025-09-26

FUJIFILM Stiffening Wire Device (SW-2000)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K251204

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HCG 2025-09-26

Optima Coil System (Optima Packing Coil System)

Applicant Balt USA, LLC

K-Number K252700

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DXG 2025-09-26

VitalStream ART Connect; VitalStream-Hemo

Applicant Caretaker Medical

K-Number K251275

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JKA 2025-09-25

Steripath® Flow™ Blood Collection System

Applicant Magnolia Medical Technologies

K-Number K251812

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LNH 2025-09-25

uMR 680

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K252371

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DZE 2025-09-25

JDEvolution Plus L and JDEvolution Plus LE

Applicant Jdentalcare Srl

K-Number K251148

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OLO 2025-09-25

RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer

Applicant Stryker Instruments

K-Number K251971

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NRY 2025-09-25

EMBOTRAP III Revascularization Device

Applicant Neuravi Limited

K-Number K251789

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