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

NGZ 2023-03-10

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

Applicant Thermo Fisher Scientific

K-Number K221198

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GEX 2023-03-10

FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

Applicant Gme German Medical Engineering GmbH

K-Number K221623

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MOF 2023-03-10

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire

Applicant Scientia Vascular, LLC

K-Number K220398

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HRX 2023-03-09

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets

Applicant Hemodia Sas

K-Number K221919

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QKB 2023-03-09

AccuContour

Applicant Manteia Technologies Co., Ltd.

K-Number K221706

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DTQ 2023-03-09

Essenz HLM

Applicant Livanova Deutschland, GmbH

K-Number K221373

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FGE 2023-03-09

MultiStage Balloon Dilatation Catheter

Applicant Dongguan TT Medical, Inc.

K-Number K222663

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DQX 2023-03-09

Vassallo GT 018 Hybrid

Applicant Filmecc Co., Ltd.

K-Number K223432

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HGX 2023-03-09

Electric breast pump (model: M5)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K-Number K223693

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MNR 2023-03-09

Wesper Lab

Applicant Wesper, Inc.

K-Number K221816

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PEK 2023-03-09

Huvex Interspinous Fusion System

Applicant Dio Medical Corp.

K-Number K223790

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NGX 2023-03-09

Powered Muscle Stimulator (Model name:MagGraver F200)

Applicant Nanjing Vishee Medical Technology Co., Ltd.

K-Number K222875

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