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

MHX 2019-10-31

ePM Series Patient monitors

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K191769

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FLE 2019-10-31

Belimed Steam Sterilizer MST-H TOP 5000

Applicant Belimed AG

K-Number K191896

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LON 2019-10-31

Vitek Densichek

Applicant bioMerieux, Inc.

K-Number K192110

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JWY 2019-10-31

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

Applicant Liofilchem s.r.l.

K-Number K192345

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LLZ 2019-10-31

VisionX 2.4

Applicant Durr Dental SE

K-Number K192743

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LPH 2019-10-31

OR3O Dual Mobility System

Applicant Smith & Nephew, Inc.

K-Number K191002

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GZF 2019-10-31

StimRouter Neuromodulation System

Applicant Bioness, Inc.

K-Number K190047

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KLE 2019-10-31

ADH19

Applicant 3M Deutschland GmbH

K-Number K192961

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DQX 2019-10-30

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile

Applicant Scientia Vascular, LLC

K-Number K192783

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NLH 2019-10-30

Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K191170

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KRD 2019-10-30

Okami Medical LOBO Vascular Occlusion System

Applicant Okami Medical

K-Number K192083

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OQY 2019-10-30

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)

Applicant Ujenzi Charitable Trust

K-Number K191264

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