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

LEJ 2019-10-28

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

Applicant Kbl GmbH

K-Number K191881

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MAX 2019-10-28

3d Cage

Applicant Fims Co., Ltd.

K-Number K180347

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PND 2019-10-28

primeMidline Catheters

Applicant Pfm Medical, Inc.

K-Number K192802

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QFO 2019-10-28

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

Applicant DiaSorin, Inc.

K-Number K192046

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DSJ 2019-10-27

EarlyVue VS30

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K190624

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NHV 2019-10-25

FILTRAY 2G Disposable Water Filters

Applicant Aqua-Tools

K-Number K191563

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NXO 2019-10-25

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

Applicant ALPCO

K-Number K191807

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KGN 2019-10-25

Cytal Wound Matrix 3-Layer

Applicant Acell, Inc.

K-Number K192725

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KRO 2019-10-25

Instruments for LINK MEGASYSTEM-C Family

Applicant LinkBio Corp.

K-Number K190181

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DWJ 2019-10-25

IOB Warming Blankets

Applicant Iob Medical, Inc.

K-Number K190221

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QSY 2019-10-25

gel-e Flex+ gel OTC

Applicant Gel-E, Inc.

K-Number K192667

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GEI 2019-10-25

Reusable Monopolar Active Cord

Applicant Us Endoscopy

K-Number K192518

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