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

LZG 2019-01-08

Omnipod Insulin Management System, Omnipod DASH Insulin Management System

Applicant Insulet Corporation

K-Number K182630

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OLO 2019-01-08

Choice Spine Navigation System

Applicant Choicespine, LP

K-Number K182721

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MUD 2019-01-08

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

Applicant Covidien, LLC

K-Number K182868

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OUY 2019-01-08

BD MAX CTGCTV2, BD MAX System

Applicant Becton, Dickinson and Company

K-Number K182692

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MAX 2019-01-07

TiWAVE-L Porous Titanium Lumbar Cage

Applicant Kalitec Medical, LLC

K-Number K182210

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JEY 2019-01-07

Stryker Facial iD Plating System

Applicant Stryker

K-Number K182305

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HRX 2019-01-07

Precision Ideal Eyes Arthroscopes

Applicant Stryker

K-Number K183470

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MAX 2019-01-07

FlareHawk Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K182114

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NHA 2019-01-07

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

Applicant Medentika GmbH

K-Number K180564

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KIF 2019-01-04

BIO-C TEMP

Applicant Angelus Industria DE Produtos Odontologicos S/A

K-Number K180199

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HIH 2019-01-04

Polygon Resection Device

Applicant Polygon Medical, Inc.

K-Number K182675

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MQK 2019-01-04

Rapid-i Kit

Applicant Vitrolife Sweden AB

K-Number K181461

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