Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

FKH 2019-08-05

TDS Standard Solution

Applicant Mesa Laboratories, Inc.

K-Number K191496

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NHA 2019-08-05

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

Applicant Prismatik Dentalcraft, Inc.

K-Number K191222

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JAA 2019-08-05

FLUOROspeed

Applicant Shimadzu Corporation

K-Number K191877

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DYB 2019-08-02

Epicardial Access System

Applicant Baylis Medical Company, Inc.

K-Number K191546

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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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