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

KPS 2023-03-10

uMI Panorama

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K223325

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FRN 2023-03-10

Avoset Infusion Pump System

Applicant Eitan Medical , Ltd.

K-Number K213744

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MBI 2023-03-10

Arthrex Knotless FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K230433

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HSX 2023-03-10

Uni Knee Resurfacing System

Applicant Overture Resurfacing, Inc.

K-Number K221292

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LHI 2023-03-10

Vial Adapter

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K222718

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OEM 2023-03-10

Lyra RSV+hMPV Assay

Applicant Quidel Corporation

K-Number K230349

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FMG 2023-03-10

lntravascular Administration Sets with Stopcock and Manifold

Applicant Baxter Healthcare Corporation

K-Number K223175

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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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