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

LZA 2017-02-08

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

Applicant Hartalega Sdn Bhd

K-Number K162491

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NFJ 2017-02-08

OptosAdvance 4.0 Software

Applicant Optos Plc.

K-Number K162039

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DXN 2017-02-08

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K162915

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KGO 2017-02-08

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

Applicant Lucenxia Prescience AG

K-Number K162852

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KDI 2017-02-08

FB-U Hemodialyzer

Applicant Nipro Medical Corporation

K-Number K160444

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MRG 2017-02-08

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

Applicant Roche Diagnostics

K-Number K162840

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OHT 2017-02-08

Handheld Diode Laser for Hair Removal

Applicant Liaoning Sidey Optoelectronics Technologies Co., Ltd.

K-Number K163173

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FRA 2017-02-08

Transformair Indoor Air Purifier

Applicant Transformair, LLC

K-Number K161468

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MQB 2017-02-08

VIVIX-S 1417N

Applicant Vieworks Co., Ltd.

K-Number K163703

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DXN 2017-02-08

Arm-Type Fully Automatic Digital Blood Pressure Monitor

Applicant Sejoy Electronics & Instruments Co., Ltd.

K-Number K161577

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NUH 2017-02-08

Smart Pain Reliever, Model LT5019

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K162479

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OMP 2017-02-08

MyNeWT Negative Pressure Wound Therapy System

Applicant Stortford Medical, LLC

K-Number K161432

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