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

PQH 2016-12-21

ulrich Transfer Set

Applicant Ulrich GmbH & Co. KG

K-Number K161723

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MUD 2016-12-21

Ox-Imager CS

Applicant Modulated Imaging, Inc.

K-Number K153426

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CFF 2016-12-21

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

Applicant Sebia

K-Number K161928

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BSK 2016-12-21

TRACOE Cuff Pressure Monitor

Applicant Tracoe Medical GmbH

K-Number K152778

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KCT 2016-12-20

K3PRO SURGICAL TRAY

Applicant Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

K-Number K160574

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NUH 2016-12-20

CP Relief Wand-OTC

Applicant Mid-America Medical Innovations, LLC

K-Number K162630

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PQM 2016-12-20

Ultravision Visual Clearing System

Applicant Alesi Surgical, Ltd.

K-Number DEN150022

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NKB 2016-12-20

CD HORIZON® Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163301

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FTM 2016-12-20

Endoform Plastics and Reconstructive Matrix

Applicant Aroa Biosurgery (Formerly Mesynthes Limited)

K-Number K162461

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PML 2016-12-20

CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems

Applicant Medos International Sàrl

K-Number K160879

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KGO 2016-12-20

Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

Applicant Hartalega Sdb. Bhd.

K-Number K160928

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MQB 2016-12-20

INNOLUX RIC

Applicant Innolux Corporation

K-Number K162344

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