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

LLZ 2019-10-01

RTapp

Applicant Segana, LLC

K-Number K191610

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NHA 2019-09-30

UF(II) Anatomic abutment

Applicant Dio Corporation

K-Number K190048

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KGC 2019-09-30

Fidmi Low Profile Enteral Feeding Device

Applicant Fidmi Medical, Ltd.

K-Number K191844

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NXC 2019-09-30

SmileAlign Orthodontic Aligner System

Applicant 3D Global Biotech, Inc.

K-Number K191774

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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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