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

MUJ 2023-03-14

RT Elements (4.0)

Applicant Brainlab AG

K-Number K223279

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QEW 2023-03-14

RevCore Thrombectomy Catheter.

Applicant Inari Medical, Inc.

K-Number K223609

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DQD 2023-03-14

HeartBuds Electronic Stethoscope

Applicant Heartbuds, LLC

K-Number K212906

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OHV 2023-03-14

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K230019

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DXQ 2023-03-14

ONE-CUF

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K230145

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IRP 2023-03-14

Leg and Foot Air Wave Pressure Therapy Device

Applicant Zhangzhou Easepal Innovation CO , Ltd.

K-Number K223464

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KWQ 2023-03-14

Cervical Plate System

Applicant Double Medical Technology, Inc.

K-Number K223753

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QVJ 2023-03-14

JETT PLASMA Medical II

Applicant Compex, Spol, S.R.O.

K-Number K213247

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OLO 2023-03-13

Remi Robotic Navigation System

Applicant Fusion Robotics, LLC

K-Number K223350

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FXX 2023-03-13

Surgical Face Mask

Applicant Wuhan Huashida Protective Products Co., Ltd.

K-Number K221352

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LPL 2023-03-13

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

Applicant Innova Vision, Inc.

K-Number K222954

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KWQ 2023-03-13

Omnia Medical Coupler-C Anterior Cervical Plate

Applicant Omnia Medical, LLC

K-Number K223321

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