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

QPB 2020-04-22

Dermapose Access

Applicant Puregraft, LLC

K-Number K200168

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FDI 2020-04-21

Lariat, Hot/Cold Snare

Applicant United States Endoscopy Group, Inc.

K-Number K200745

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FMI 2020-04-21

Droplet Pen Needle 34G

Applicant Htl-Strefa S.A

K-Number K192082

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JKA 2020-04-21

Bevel Up Holder

Applicant Nsp Tech Pte, Ltd.

K-Number K193074

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OVD 2020-04-21

EL CAPITAN Anterior Lumber Interbody System

Applicant Astura Medical, LLC

K-Number K192492

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KRA 2020-04-21

Instylla Microcatheter

Applicant Instylla, Inc.

K-Number K200744

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EZL 2020-04-21

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Applicant Pathway, LLC

K-Number K192034

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PLR 2020-04-21

Galileo Vertebral Body Replacement Device

Applicant Bright Spine

K-Number K192145

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GCJ 2020-04-21

Pristine Scope

Applicant Pristine Surgical

K-Number K193161

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QAS 2020-04-21

NinesAI

Applicant Nines, Inc.

K-Number K193351

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GCJ 2020-04-21

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

Applicant Dannik

K-Number K200053

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GXY 2020-04-21

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

Applicant Wuhan Greentek Pty , Ltd.

K-Number K200162

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