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

HRS 2019-09-30

APTUS Wrist Spanning Plates 2.5

Applicant Medartis AG

K-Number K191848

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OAP 2019-09-30

Hair Boom 69, Hair Boom Air, Ulike Hair UpUp

Applicant Wontech Co., Ltd.

K-Number K192425

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KLE 2019-09-29

Visalys Tooth Primer

Applicant Kettenbach GmbH & Co. KG

K-Number K191524

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OLO 2019-09-27

Precision Spine Navigation Instrumentation

Applicant Precision Spine, Inc.

K-Number K181606

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OYX 2019-09-27

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

Applicant Cepheid

K-Number K190076

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FDT 2019-09-27

FUJIFILM Duodenoscope Model ED-580XT

Applicant Fujifilm Corporation

K-Number K191747

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OXO 2019-09-27

Smart-C

Applicant Turner Imaging Systems, Inc.

K-Number K190024

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MNR 2019-09-27

Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant

Applicant Embla Systems

K-Number K180001

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CAC 2019-09-27

CATSmart

Applicant Fresenius Kabi AG

K-Number K192368

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FMF 2019-09-27

EpiFaith Syringe

Applicant Flat Medical Co., Ltd.

K-Number K192421

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LZO 2019-09-27

MiniMAX

Applicant Medacta International S.A.

K-Number K192352

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DTZ 2019-09-27

Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir

Applicant Medtronic, Inc.

K-Number K191444

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