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

OWN 2016-05-20

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K160416

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NVM 2016-05-20

BIB Stent Placement Catheter

Applicant NuMED, Inc.

K-Number K160889

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MQB 2016-05-20

ViZion DR + Wireless

Applicant Viztek, LLC

K-Number K160810

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LJT 2016-05-20

BardPort®, SlimPort®, and X-Port® Implanted Ports

Applicant C.R. Bard, Inc.

K-Number K153359

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LZO 2016-05-20

MasterLoc Stem

Applicant Medacta International

K-Number K160289

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LXB 2016-05-20

Baha 5 Power Sound Processor

Applicant Cochlear Americas

K-Number K161123

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LNH 2016-05-20

Trillium Oval V 5.1 MRI System

Applicant Hitachi Medical Systems America, Inc.

K-Number K160152

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LEJ 2016-05-20

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy

Applicant Sunfire Industries, Inc.

K-Number K152423

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NUC 2016-05-20

Dr. Wolff Vagisan Moisturising Cream

Applicant Dr. August Wolff GmbH & Co. KG Arzeimittel

K-Number K152507

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NHA 2016-05-20

TruAbutment DS

Applicant Truabutment

K-Number K152559

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OXO 2016-05-20

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

Applicant Gemss Medical Systems Co., Ltd.

K-Number K160065

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LBH 2016-05-20

Oral-B 5% Sodium Fluoride Varnish

Applicant Young Dental Manufacturing Co. 1, LLC

K-Number K153334

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