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

PLA 2018-05-17

EnsoETM

Applicant Advanced Cooling Therapy, Inc. D/B/A Attune Medical

K-Number K180742

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OLO 2018-05-17

Navigated INFINITY Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K181111

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FIE 2018-05-17

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

Applicant Dimesol, Inc.

K-Number K171505

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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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