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

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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PHX 2017-02-21

SMR TT Metal Back Glenoid, Bone Graft instruments

Applicant Lima Corporate S.P.A.

K-Number K161120

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EBW 2017-02-21

ELECTROmatic

Applicant Kaltenbach & Voigt Gmgh

K-Number K163317

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HRS 2017-02-21

AlignMATE™ Lapidus Arthrodesis System

Applicant Arthrosurface, Inc.

K-Number K162391

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