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

NQQ 2025-07-02

OPUSWAVE Dual Sensor Imaging System

Applicant Terumo Cardiovascular Systems Thi Plant

K-Number K250684

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MQV 2025-07-02

OsteoFlo HydroFiber

Applicant SurGenTec, LLC

K-Number K251720

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GEX 2025-07-02

SurgiLight 1470 Diode Laser System (Model:Halo)

Applicant Micro-Energy Medical Technology Co., Ltd.

K-Number K251049

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GCJ 2025-07-02

Boehringer Laboratories Liver Retractor

Applicant Boehringer Laboratories, LLC

K-Number K243399

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GCJ 2025-07-02

8 mm Assist Cannula; 12 mm Assist Cannula

Applicant Intuitive Surgical, Inc.

K-Number K251490

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ITI 2025-07-02

Electric Wheelchair (HG-630)

Applicant Zhejiang Automwheel Tech Co., Ltd.

K-Number K251285

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DXN 2025-07-02

G0 Blood Pressure Monitoring System (G0)

Applicant Aktiia SA

K-Number K250415

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JWH 2025-07-02

EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)

Applicant Encore Medical L.P.

K-Number K251241

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LPL 2025-07-02

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K-Number K243868

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IWB 2025-07-02

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)

Applicant Elekta Solutions AB

K-Number K250391

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PZL 2025-07-02

CS-Pro MED

Applicant Curative Sound Therapeutics

K-Number K250779

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OXO 2025-07-02

Orthoscan TAU Mini C-Arm

Applicant Ziehm-Orthoscan, Inc.

K-Number K250587

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