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

GEX 2016-09-26

LUCERNA Dental Laser

Applicant Viax Dental Lab

K-Number K161185

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QEW 2016-09-26

Penumbra Aspiration System

Applicant Penumbra, Inc.

K-Number K161506

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HSB 2016-09-26

DePuy Synthes TFNA Augmentation System

Applicant Synthes (USA) Products, LLC

K-Number K160167

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HRX 2016-09-26

PORTAGE System

Applicant Baylis Medical Company, Inc.

K-Number K161878

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ONY 2016-09-26

Sensor Monitored Alimentary Restriction Therapy (SMART) Device

Applicant Scientific Intake

K-Number DEN150033

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DSK 2016-09-26

Endophys Blood Pressure Monitor

Applicant Endophys Holdings, LLC

K-Number K160945

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GCJ 2016-09-26

Xenocor Xenoscope Laparoscopic System

Applicant Xenocor, Inc.

K-Number K161838

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GEI 2016-09-26

PK AIM

Applicant Gyrus Acmi, Inc.

K-Number K161825

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MLR 2016-09-26

STERRAD 100NX Sterilizer with ALLClearTM Technology

Applicant Advanced Sterilization Products

K-Number K160903

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JKA 2016-09-23

BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube

Applicant Becton, Dickinson and Company

K-Number K160657

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JWH 2016-09-23

EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)

Applicant Encore Medical L.P.

K-Number K161945

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MNH 2016-09-23

FixxSure® X-Link

Applicant Innovasis, Inc.

K-Number K162143

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