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 2020-04-21

Pristine Scope

Applicant Pristine Surgical

K-Number K193161

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QAS 2020-04-21

NinesAI

Applicant Nines, Inc.

K-Number K193351

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GCJ 2020-04-21

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

Applicant Dannik

K-Number K200053

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GXY 2020-04-21

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

Applicant Wuhan Greentek Pty , Ltd.

K-Number K200162

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DXN 2020-04-21

Globalcare Blood Pressure Monitor

Applicant Globalcare Medical Technology Co., Ltd.

K-Number K192609

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PNN 2020-04-21

DIBS (Digital Indirect Bonding System)

Applicant Orthoselect, LLC

K-Number K192701

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KRR 2020-04-20

MOTO PFJ System

Applicant Medacta International S.A.

K-Number K200122

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QEZ 2020-04-20

QuickClear Mechanical Thrombectomy System

Applicant Volcano Atheromed, Inc.

K-Number K193197

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QBP 2020-04-20

CapKlenZ

Applicant Star Mountain Medical, Inc.

K-Number K192382

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IYE 2020-04-20

Sentinel

Applicant C-Rad Positioning AB

K-Number K200600

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DRG 2020-04-20

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

Applicant Vitalconnect, Inc.

K-Number K193343

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NUC 2020-04-20

KY Grosz Liquid

Applicant Rb Health (Us), LLC

K-Number K193032

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