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

GCJ 2022-06-27

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula

Applicant Covidien

K-Number K213818

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IYN 2022-06-27

Venue Fit

Applicant GE Medical Systems

K-Number K220848

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EHD 2022-06-27

DT-703

Applicant Ecotron Co., Ltd.

K-Number K221233

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FDI 2022-06-27

Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K220790

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HGX 2022-06-27

Wearable Breast Pump (Model S10)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K-Number K220309

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IYN 2022-06-27

Venue

Applicant GE Medical Systems

K-Number K220851

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GEI 2022-06-27

CiRX Single use electrosurgical pencil with non-coated and coated electrode

Applicant Ningbo Shun YE Medical Company, Ltd.

K-Number K213786

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PLV 2022-06-27

Navident

Applicant Claronav, Inc.

K-Number K210947

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OZE 2022-06-24

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

Applicant Abbott Diagnostics Scarborough, Inc.

K-Number K220801

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DZE 2022-06-24

Noris Medical Dental Implants System - Cortical

Applicant Noris Medical , Ltd.

K-Number K210852

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FXX 2022-06-24

Procedure Mask

Applicant Little Rapids Corporation

K-Number K220377

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QQE 2022-06-24

OTOPLAN

Applicant Cascination AG

K-Number K220300

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