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

KWQ 2019-05-29

Fuji Cervical Plate System

Applicant Altus Partners, LLC

K-Number K183084

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FRO 2019-05-29

Silver High Performance Dressing

Applicant Advanced Medical Solutions, Ltd.

K-Number K183645

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KNG 2019-05-29

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)

Applicant Vcomin Technology Limited

K-Number K182526

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EBG 2019-05-29

LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2

Applicant DMG Chemisch-Pharmazeutische Fabrik GmbH

K-Number K183337

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LNH 2019-05-29

uMR 780, uMR 790

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K191157

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FFK 2019-05-29

Swiss LithoClast Trilogy

Applicant E.M.S Electro Medical Systems S.A

K-Number K191124

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KNT 2019-05-29

Entuit PEG, Entuit PEGJ

Applicant Wilson-Cook Medical, Inc.

K-Number K183336

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DRA 2019-05-29

MitraClip G4 Steerable Guide Catheter

Applicant Abbott

K-Number K190167

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FED 2019-05-29

Peel-Away Introducer

Applicant Cook Incorporated

K-Number K182403

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JAK 2019-05-29

Brain Perfusion (BP) application

Applicant Philips Medical Systems Nederland B.V.

K-Number K182716

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ESW 2019-05-29

Segmented Esophageal Stent System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K182910

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OVD 2019-05-29

Juliet® Ti LL Lumbar Interbody Device

Applicant Spineart

K-Number K190877

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