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

QFM 2023-03-17

Viz AAA

Applicant Viz. Ai, Inc.

K-Number K223443

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PCH 2023-03-16

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

Applicant Biofire Diagnostics, LLC

K-Number K230404

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NAY 2023-03-16

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K223095

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OLU 2023-03-16

iSyncBrain©-C

Applicant iMediSync, Inc.

K-Number K222838

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OBP 2023-03-16

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+

Applicant Magstim Company, Ltd.

K-Number K223154

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HGX 2023-03-16

MilkMate Breast Pump

Applicant Milkmate Products, Inc.

K-Number K223084

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NAY 2023-03-16

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System

Applicant Intuitive Surgical, Inc.

K-Number K222839

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LZO 2023-03-16

BENCOX Delta Option Heads

Applicant Corentec Co., Ltd.

K-Number K223828

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ITI 2023-03-16

Electric Wheelchair

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K223393

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LZA 2023-03-16

Nitrile Examination Gloves

Applicant Ecoglove Medical Manufacturing Company Limited

K-Number K222813

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FRO 2023-03-16

Sterile Silver Alginate Wound Dressing

Applicant Qingdao Bright Moon Biomedical Materials Co., Ltd.

K-Number K220673

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NXC 2023-03-16

Ensmile

Applicant Ensmile Pvt, Ltd.

K-Number K222619

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