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

KWS 2017-02-22

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K-Number K162800

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LZA 2017-02-22

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)

Applicant Blue Sail Medical Co.,Ltd

K-Number K163126

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IYN 2017-02-22

HS70A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K163691

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BWF 2017-02-21

VibraPEP

Applicant Medica Holdings, LLC

K-Number K163091

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DXN 2017-02-21

Omron HEM-6400T-Z Wrist Blood Pressure Monitor

Applicant Omron Healthcare, Inc.

K-Number K163045

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HRS 2017-02-21

VariAx Distal Radius Plating System, VariAx 2 System

Applicant Stryker GmbH

K-Number K162841

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QEZ 2017-02-21

ClearLumen II Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K-Number K163051

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DZE 2017-02-21

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure

Applicant Dio Corporation

K-Number K161987

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MJH 2017-02-21

TRU Legionella

Applicant Meridian Bioscience, Inc.

K-Number K163273

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QEY 2017-02-21

SpeedLyser Infusion Catheter Kit

Applicant AngioDynamics, Inc.

K-Number K170258

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KTT 2017-02-21

Arrowhead Mini-Rail Fixator

Applicant Arrowhead De, LLC

K-Number K162032

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HWC 2017-02-21

SurgTech Trauma System

Applicant Surgtech, Inc.

K-Number K161894

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