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

OWB 2017-05-19

OEC Elite

Applicant Oec Medical Systems, Inc.

K-Number K170752

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MAX 2017-05-19

DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K162212

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HBE 2017-05-19

OsteoMed PINNACLE Driver

Applicant Osteomed

K-Number K162542

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IYN 2017-05-19

E5 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K170303

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JKA 2017-05-19

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

Applicant Sol-Millennium Medical, Inc.

K-Number K163073

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PGW 2017-05-19

StealthStationTM S8 ENT Software

Applicant Medtronic Navigation, Inc.

K-Number K170018

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BTR 2017-05-19

Frova Intubating Introducer

Applicant William Cook Europe Aps

K-Number K161813

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PSL 2017-05-18

Vitamin D 200M Assay for the Topaz System

Applicant Ab Sciex, LLC

K-Number DEN170019

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KNT 2017-05-18

Barone Jejunostomy Catheter Set

Applicant Cook Incorporated

K-Number K160567

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KPO 2017-05-18

bibag

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K162716

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KNT 2017-05-18

Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube

Applicant Cook Incorporated

K-Number K160509

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HIF 2017-05-18

LaparoLight Veress Needle

Applicant Buffalo Filter, LLC

K-Number K171139

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