Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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LNH 2020-04-20

uMR 570

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K200024

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LHI 2020-04-20

Rio Vial-to-Bag Drug Reconstitution Device

Applicant Icu Medical

K-Number K192154

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GEI 2020-04-20

CarpX

Applicant Pavmed, Inc.

K-Number K200559

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HWC 2020-04-18

S4 Screw System

Applicant Subchondral Solutions, Inc.

K-Number K191995

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