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

MAX 2019-12-20

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K-Number K192718

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KDN 2019-12-20

Paragonix SherpaPak Pancreas Transport System

Applicant Paragonix Technologies

K-Number K191440

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QAS 2019-12-20

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K192383

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PEW 2019-12-20

UroLift System (UL400)

Applicant Neotract, Inc.

K-Number K193269

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DQA 2019-12-20

Pulse Oximeter

Applicant Nonin Medical, Inc.

K-Number K191403

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GEI 2019-12-20

Surgical Direct Hand-held Laparoscopic Instruments

Applicant Surgical Direct, Inc.

K-Number K193018

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GEI 2019-12-20

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device

Applicant Applied Medical Resources Corp.

K-Number K193292

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QIH 2019-12-20

QLAB Advanced Quantification Software

Applicant Philips Health Care

K-Number K191647

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GEI 2019-12-20

RHIN1 Stylus

Applicant Aerin Medical, Inc.

K-Number K192471

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HEB 2019-12-20

Unscented W long plastic and cardboard applicator tampons

Applicant Ontex Bvba

K-Number K191666

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QBH 2019-12-20

Unyvero LRT BAL Application

Applicant Curetis GmbH

K-Number K191967

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LLZ 2019-12-20

AVIEW Modeler

Applicant Coreline Soft Co., Ltd.

K-Number K192040

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