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

GEI 2020-04-22

SYLFIRM X

Applicant VIOL Co., Ltd.

K-Number K200185

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QEW 2020-04-22

Indigo Aspiration System Lightning Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K200771

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MQV 2020-04-22

DB-Orthopedics

Applicant Dimensional Bioceramics, LLC

K-Number K200752

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MWI 2020-04-22

Masimo Centroid System

Applicant Masimo Corporation

K-Number K191882

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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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