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

GCJ 2016-09-29

EZEE RETRIEVAL

Applicant Genicon, Inc.

K-Number K162059

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GEX 2016-09-29

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

Applicant Iridex Corporation

K-Number K162416

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GBM 2016-09-29

SpeediCath Flex Coude

Applicant Coloplast Corp.

K-Number K161672

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EFB 2016-09-29

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head

Applicant Dental Savings Club

K-Number K160410

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OVD 2016-09-29

ELSA Spacers

Applicant Globus Medical, Inc.

K-Number K161379

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NKB 2016-09-28

NuVasive® Reline® System

Applicant Nu Vasive, Incorporated

K-Number K161014

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EBI 2016-09-28

PINK CAD/CAM disc

Applicant Polident D.O.O., Dental Products Industry

K-Number K153546

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OVD 2016-09-28

Avenue® T TLIF Cage

Applicant Ldr Spine USA, Inc.

K-Number K161173

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NBW 2016-09-28

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

Applicant Infopia Co, Ltd.

K-Number K160365

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KLW 2016-09-28

Sound Options Tinnitus Treatment

Applicant Sound Options Tinnitus Treatments, Inc.

K-Number K161562

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IYN 2016-09-28

Acuson Freestyle Ultrasound System

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K162417

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BTA 2016-09-28

Aprima Smartesis Centesis Pump

Applicant Cook Incorporated

K-Number K161002

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