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

IYE 2017-11-09

BioZorb Marker GOLD / LP Marker GOLD

Applicant Focal Therapeutics

K-Number K171467

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DQX 2017-11-09

WATCHDOG Hemostasis Valve Kit

Applicant Boston Scientific Corporation

K-Number K172453

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DRS 2017-11-09

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

Applicant Smiths Medical Asd, Inc.

K-Number K172458

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MHX 2017-11-09

MX40 Release B.07

Applicant Philips Medical Systems

K-Number K172226

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IZQ 2017-11-09

ulrichINJECT CT motion

Applicant Ulrich GmbH & Co. KG

K-Number K171392

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JWH 2017-11-09

PROLIXUS TOTAL KNEE SYSTEM

Applicant Otis Biotech Co., Ltd.

K-Number K170534

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MQB 2017-11-09

Aquarius 8600 1417WCI; Aquarius 8600 1717WCI

Applicant Imaging Dynamics Company , Ltd.

K-Number K173273

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JAK 2017-11-09

Philips CT Big Bore

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K171850

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DQY 2017-11-09

Odyssey Micro Catheter

Applicant Heraeus Medical Components, LLC

K-Number K170664

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MQP 2017-11-09

FORTIFY Corpectomy Spacers

Applicant Globus Medical, Inc.

K-Number K162315

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MJN 2017-11-08

ER-REBOA Catheter

Applicant Prytime Medical Devices, Inc.

K-Number K172790

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LZO 2017-11-08

C2 femoral stem

Applicant Lima Corporate S.P.A.

K-Number K170473

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