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

QIH 2019-11-13

EchoGo Core

Applicant Ultromics, Ltd.

K-Number K191171

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LKN 2019-11-13

AMICUS Separator System

Applicant Fresenius Kabi AG

K-Number K192150

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FLL 2019-11-13

Infrared Thermometer Model MD-H30

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K191570

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NKB 2019-11-13

GMA 2.0 Pedicle Screw System

Applicant Grafton Medical Alliance

K-Number K192915

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HRS 2019-11-12

ARIX Wrist System

Applicant Jeil Medical Corporation

K-Number K191972

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PCH 2019-11-12

xTAG Gastrointestinal Pathogen Panel (GPP)

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K191161

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IYE 2019-11-12

IDENTIFY

Applicant Varian Medical Systems, Inc.

K-Number K192968

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MQB 2019-11-12

FDR D-EVO III flat panel detector system

Applicant Fujifilm Corporation

K-Number K192932

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FDS 2019-11-12

PENTAX Medical Video Upper GI Scopes (EG Family)

Applicant Pentax of America, Inc.

K-Number K190799

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GEX 2019-11-12

LaseMD LEO Laser System

Applicant Lutronic Global

K-Number K192331

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NJM 2019-11-12

Clear21

Applicant World Class Technology Corporation

K-Number K192202

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DSP 2019-11-12

AC3 Series Intra-Aortic Balloon Pump (IABP)

Applicant Arrow International, Teleflex

K-Number K192238

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