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

IOR 2018-05-17

Athena 190

Applicant Medical Rehab Products, LLC

K-Number K173360

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DXK 2018-05-17

Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter

Applicant Boston Scientific Corporation

K-Number K181042

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MBH 2018-05-17

Zimmer Persona Personalized Knee System

Applicant Zimmer, Inc.

K-Number K172524

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LXJ 2018-05-17

MindMotion(TM) GO

Applicant Mindmaze SA

K-Number K173931

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FLL 2018-05-17

Infrared Thermometer

Applicant Shenzhen Jiacom Technology CO ., Ltd.

K-Number K172894

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LOX 2018-05-17

Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter

Applicant Meril Life Sciences Private Limited

K-Number K181023

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ODP 2018-05-17

icotec Interbody Cage System

Applicant Icotec AG

K-Number K172480

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QEW 2018-05-17

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical, Inc.

K-Number K180466

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JWH 2018-05-16

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System

Applicant Conformis, Inc.

K-Number K180906

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LPL 2018-05-16

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens

Applicant Menicon Co, Ltd.

K-Number K180819

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EKX 2018-05-16

IS3

Applicant Hiossen, Inc.

K-Number K180527

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HRS 2018-05-16

Additive Orthopaedics Patient Specific 3D Printed Bone Segments

Applicant Additive Orthopaedics, LLC

K-Number K180239

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