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

DYB 2019-05-30

FlexSeal Introducer Sheath with Hydrophilic Coating

Applicant Freudenberg Medical Mis, Inc.

K-Number K190628

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LFL 2019-05-30

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K-Number K190160

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QHA 2019-05-30

Qangio XA 3D

Applicant Medis Medical Imaging Systems BV

K-Number K182611

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LLZ 2019-05-30

ASHK100G

Applicant Lg Electronics

K-Number K191188

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JQC 2019-05-30

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

Applicant Emcyte Corporation

K-Number K183205

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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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