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

OAS 2016-10-20

Green Smart (Model: PHT-35LHS)

Applicant VATECH Co., Ltd.

K-Number K162660

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GCJ 2016-10-20

LiVac Retractor System

Applicant Livac Pty, Ltd.

K-Number K162445

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JAQ 2016-10-20

Advanced Breast Template System

Applicant Varian Medical Systems, Inc.

K-Number K161540

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MAV 2016-10-20

Fluent inflation device

Applicant Vascular Solutions, Inc.

K-Number K162272

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LZA 2016-10-20

DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K161422

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PEK 2016-10-19

Z-Clamp ISP System

Applicant Zavation, LLC

K-Number K161016

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GXY 2016-10-19

TENS Electrodes

Applicant Cathay Manufacturing Corp.

K-Number K160081

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OLP 2016-10-19

Pulsaderm Acne Device

Applicant Nutra Luxe MD, LLC

K-Number K161941

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LZA 2016-10-19

Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)

Applicant Medline Industries, Inc.

K-Number K161473

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LBS 2016-10-19

HDL-Cholesterol Gen.4

Applicant Roche Diagnostics Operations (Rdo)

K-Number K162593

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OMP 2016-10-19

Avance Tubing, Avance Y-Connector, Avance ViewPad

Applicant Molnlycke Health Care Us, LLC

K-Number K161797

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LPH 2016-10-19

Klassic HD Hip System

Applicant Total Joint Othopedics, Inc.

K-Number K161073

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