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

MCW 2017-10-30

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

Applicant Avinger, Inc.

K-Number K172236

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DQD 2017-10-30

Stethee Pro

Applicant M3Dicine Pty , Ltd.

K-Number K172296

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MOT 2017-10-27

SANGRAY

Applicant Hitachi , Ltd.

K-Number K172087

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MLY 2017-10-27

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

Applicant Gebauer Company

K-Number K172028

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CEC 2017-10-27

Abbott Architect Free T4

Applicant Abbott Laboratories

K-Number K173122

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LBI 2017-10-27

Skylife

Applicant Neolight, LLC

K-Number K170585

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IYO 2017-10-27

Biim Diagnostic Ultrasound System

Applicant Biim Ultrasound AS

K-Number K173138

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IYE 2017-10-27

LINACwatch, LinacView

Applicant Qualiformed Sarl

K-Number K172534

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CBK 2017-10-27

Puritan Bennett 980 Ventilator System

Applicant Covidien

K-Number K162738

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IYN 2017-10-27

C5 Diagnostic Ultrasound System

Applicant Guangzhou Sonostar Technologies Co., Ltd.

K-Number K171926

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OQG 2017-10-27

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

Applicant Total Joint Orthopedics, Inc.

K-Number K173104

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MUE 2017-10-27

ASPIRE Cristalle

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K173132

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