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

FLE 2017-02-23

Family of Steam sterilizers B17 B22 Series

Applicant Cefla S.C.

K-Number K161848

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HJO 2017-02-23

VISULUX

Applicant Carl Zeiss Meditec, AG

K-Number K161607

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OAT 2017-02-23

Dual Top Screw System

Applicant Jeil Medical Corporation

K-Number K161335

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OLO 2017-02-23

Stryker OrthoMap Versatile Hip System

Applicant Stryker Corporation

K-Number K162937

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BWF 2017-02-23

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM

Applicant Medinet Srl

K-Number K160837

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IYN 2017-02-23

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

Applicant Medisono, LLC

K-Number K163688

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LLZ 2017-02-23

Lung Nodule Assessment and Comparison Option (LNA)

Applicant Philips Medical Systems Nederland B.V.

K-Number K162484

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OOD 2017-02-23

GalaFORM 3D

Applicant Tepha, Inc.

K-Number K162922

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MXD 2017-02-23

Reveal LINQ

Applicant Medtronic, Inc.

K-Number K162855

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HSN 2017-02-22

PROPHECY INVISION Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K-Number K162795

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DSH 2017-02-22

my Patch sl

Applicant Dms-Service, LLC

K-Number K163535

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HAW 2017-02-22

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

Applicant Stryker Corporation

K-Number K162929

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