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 2016-06-02

Helios III

Applicant Laseroptek Co., Ltd.

K-Number K152856

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FOZ 2016-06-02

PowerGlide Pro Midline Catheter

Applicant C.R. Bard, Inc.

K-Number K153280

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GCJ 2016-06-02

LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application

Applicant Smith & Nephew

K-Number K153606

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NHA 2016-06-02

NobelDesign Software

Applicant Nobel Biocare AB

K-Number K153036

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NHA 2016-06-02

VARIOunite

Applicant Thommen Medical AG

K-Number K160244

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MOS 2016-06-02

16ch Tx/Rx Knee SPEEDER

Applicant Quality Electrodynamics, LLC

K-Number K161193

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NUC 2016-06-02

Gun Oil, Pink, Gun Oil H2O, Pink Water

Applicant Empowered Products, Inc.

K-Number K152918

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GEX 2016-06-02

O-pel Laser and families of probe delivery devices

Applicant Precise Light Surgical

K-Number K160012

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FRO 2016-06-02

MTR550 (Tentative) Antimicrobial Silver Wound Gel

Applicant Medical Technology Research, Inc.

K-Number K152519

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LLL 2016-06-01

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

Applicant Inova Diagnostics, Inc.

K-Number K152635

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DXN 2016-06-01

AGE Automatic Upper Arm Blood Pressure Monitor

Applicant Ageless Health Industrial Co., Ltd.

K-Number K153552

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FPA 2016-06-01

Hospira Administration Sets

Applicant Hospira, Inc.

K-Number K160870

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