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

NRY 2019-08-02

046 Zenith Flex

Applicant Inneuroco, Inc.

K-Number K190338

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IZL 2019-08-02

MobileDiagnost wDR 2.2

Applicant Sedecal., Sa.

K-Number K191813

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CBK 2019-08-02

HAMILTON-T1, HAMILTON-C1

Applicant Hamilton Medical AG

K-Number K181216

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NKB 2019-08-02

Elaris Pedicle Screw System

Applicant Spinewelding AG

K-Number K183091

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GGT 2019-08-02

ADVIA Centaur Erythropoietin (EPO) assay

Applicant Axis-Shield Diagnostics Limited

K-Number K183088

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KNS 2019-08-02

Rezum System

Applicant Nxthera (A Boston Scientific Company)

K-Number K191505

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GEI 2019-08-02

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

Applicant Lumendi, LLC

K-Number K183112

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GEX 2019-08-02

Primelase Excellence

Applicant High Technology Products S.L.U

K-Number K191321

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DXN 2019-08-02

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K181154

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BTG 2019-08-02

Single Use Cytology Brush BC-205D

Applicant Olympus Medical Systems Corp.

K-Number K190293

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JOJ 2019-08-02

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape

Applicant Intertape Polymer, Inc.

K-Number K191741

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MWI 2019-08-02

DynoSense Vital Sign Measuring System

Applicant Dynosense Corp.

K-Number K190090

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