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

DQY 2017-10-20

GuideLiner V3 Catheter

Applicant Vascular Solutions, Inc.

K-Number K172090

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EWO 2017-10-20

GSI Novus

Applicant Grason-Stadler, Inc.

K-Number K172403

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IYE 2017-10-20

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D

Applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten

K-Number K160405

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KPR 2017-10-20

Discovery XR656 HD

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K172869

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DQX 2017-10-20

Heraeus TMW Guidewire

Applicant Heraeus Medical Components, LLC

K-Number K173052

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ORR 2017-10-20

ClearPoint System

Applicant Mri Interventions, Inc.

K-Number K171257

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NUH 2017-10-19

Avail

Applicant Omron Healthcare, Inc.

K-Number K172079

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DQY 2017-10-19

065 Zenith, 074 Zenith

Applicant Inneuroco, Inc.

K-Number K171672

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OOE 2017-10-19

VICTUS Femtosecond Laser Platform

Applicant Technolas Perfect Vision GmbH

K-Number K171014

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ODE 2017-10-19

EsophyX Z, EsophyX2 HD

Applicant Endogastric Solutions, Inc.

K-Number K172811

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NBW 2017-10-19

CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K170614

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KLW 2017-10-19

audifon Tinnitus-Module

Applicant Audiofon USA, Inc.

K-Number K171243

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