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

PNO 2017-09-22

ULTRASCORE Focused Force PTA Balloon

Applicant C. R. Bard

K-Number K172571

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GEX 2017-09-22

Sterling Supreme Diode Laser

Applicant CAO Group, Inc.

K-Number K171986

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NUH 2017-09-22

WiTouch Pro, WiTouch, Neubac

Applicant Hollywog, LLC

K-Number K171599

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MED 2017-09-22

SYSTEM 1E Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K-Number K170956

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QYX 2017-09-22

NOWCARDIO SYSTEM

Applicant Contex International Technologies (Canada), Inc.

K-Number K162956

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NUC 2017-09-22

Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry

Applicant Neo Cosmetique

K-Number K163674

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OXF 2017-09-22

SERI Contour

Applicant Sofregen Medical, Inc.

K-Number K172545

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KPS 2017-09-22

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

Applicant University of Texas Medical School AT Houston, Texas

K-Number K171303

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FPA 2017-09-22

IV Fat Emulsion Administration Sets

Applicant Baxter Healthcare Corporation

K-Number K172544

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GEI 2017-09-22

Thermage FLX System and Accessories

Applicant Solta Medical

K-Number K170758

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GEI 2017-09-22

TempSure

Applicant Cynosure, Inc.

K-Number K171262

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KWQ 2017-09-22

Matira™ Anterior Cervical System

Applicant Kalitec Direct, LLC

K-Number K172086

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