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

BTR 2017-05-19

Frova Intubating Introducer

Applicant William Cook Europe Aps

K-Number K161813

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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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NKG 2017-05-18

The Solstice OCT System

Applicant Life Spine, Inc.

K-Number K170804

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ONY 2017-05-18

SmartByte Device

Applicant Scientific Intake

K-Number K171165

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MUU 2017-05-18

Lipogems System

Applicant Lipogems International Spa

K-Number K171135

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MAI 2017-05-18

HEALIX ADVANCE Anchor with PERMATAPE Suture

Applicant Medos International SARL

K-Number K170639

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NLH 2017-05-18

Supreme and Response Electrophysiology Catheters

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K161272

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MQB 2017-05-17

Nexus DR Digital X-ray Imaging System

Applicant Varex Imaging Corporation

K-Number K171138

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DXN 2017-05-17

A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor

Applicant A&D Company, Ltd.

K-Number K170196

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