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

IOR 2016-12-28

Kuschall Advance Manual Wheelchair

Applicant Invacare Corporation

K-Number K162696

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IOR 2016-12-28

Kuschall Champion Manual Wheelchair

Applicant Invacare Corporation

K-Number K162686

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JEC 2016-12-28

Medline ReNewal Reprocessed Stryker External Fixation Devices

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K163028

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IOR 2016-12-28

Kuschall K-Series Attract Manual Wheelchair

Applicant Invacare Corporation

K-Number K162692

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DQA 2016-12-28

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter

Applicant Masimo Corporation

K-Number K162675

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LLZ 2016-12-28

ClearView cCAD

Applicant Clearview Diagnostics, Inc.

K-Number K161959

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KIJ 2016-12-27

SMARTO

Applicant Jeil Medical Corporation

K-Number K163308

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KWS 2016-12-27

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K-Number K161789

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JPA 2016-12-26

Sysmex CS-2100i

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K162688

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NBW 2016-12-23

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K161299

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DQA 2016-12-23

Model X-100C CO-Met™ Oximetry System

Applicant Nonin Medical, Inc.

K-Number K160231

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FGE 2016-12-23

Zilver 635 Biliary Stent

Applicant Cook Ireland, Ltd.

K-Number K163018

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