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

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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NHA 2023-03-09

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K221301

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QJP 2023-03-09

CEREGLIDE 71 Intermediate Catheter

Applicant Cerenovus, Inc.

K-Number K221930

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DQY 2023-03-09

CPS Locator 3D Delivery Catheter

Applicant CenterPoint Systems, LLC

K-Number K230363

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LON 2023-03-09

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

Applicant Biomerieux Sa, Inc.

K-Number K222430

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JAK 2023-03-09

Spectral Bone Marrow

Applicant Ge Medical Systems, LLC

K-Number K223514

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