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

IYN 2017-10-05

LinkQuest Diagnostic Ultrasound System model SQ860

Applicant Linkquest, Inc.

K-Number K172059

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OBP 2017-10-05

MagVita TMS Therapy w/MagPro R20

Applicant Tonica Elektronik A/S

K-Number K172667

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MQB 2017-10-05

Aquarius 8600 1417WC

Applicant Imaging Dynamics Company , Ltd.

K-Number K171175

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KWQ 2017-10-05

Shanghai Sanyou CARMEN Cervical Fusion System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K163366

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FLL 2017-10-04

ri-former Predictive Thermometer

Applicant Rudolf Riester GmbH

K-Number K171182

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MBH 2017-10-04

EMPOWR Porous Knee System

Applicant Encore Medical L.P.

K-Number K171991

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PSY 2017-10-04

Philips IntelliSite Pathology Solution

Applicant Philips Medical Systems Nederland B.V.

K-Number K172174

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HRX 2017-10-04

Reprocessed Shavers/Burs

Applicant Renovo, Inc.

K-Number K172092

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FGE 2017-10-04

CRE RX Biliary Balloon Dilatation Catheter

Applicant Boston Scientific Corporation

K-Number K172520

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IYN 2017-10-04

Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

Applicant Philips Health Care

K-Number K172607

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LFL 2017-10-04

Ultrasonic Generator

Applicant Olympus Medical Systems Corp.

K-Number K172691

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GEI 2017-10-04

HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal

Applicant Conmed Corporation

K-Number K172671

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