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

CGR 2021-04-13

IDS Cortisol

Applicant Immunodiagnostic Systems , Ltd.

K-Number K202136

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HKI 2021-04-13

RetCam Envision

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K203500

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HIR 2021-04-13

Flyte

Applicant Pelvital USA, Inc.

K-Number K210764

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HRS 2021-04-13

Volition Plating System

Applicant Ortho Solutions UK , Ltd.

K-Number K210658

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ELC 2021-04-13

EndoPilot2

Applicant Schlumbohm GmbH & Co. KG

K-Number K202906

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ONG 2021-04-13

SR-1 Skin Treatment System

Applicant AVAVA, Inc.

K-Number K202884

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OKC 2021-04-12

SecurAcath

Applicant Interrad Medical, Inc.

K-Number K210629

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OLO 2021-04-12

OMNIVision system

Applicant Corin USA

K-Number K203751

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MAX 2021-04-12

Idys ALIF 3DTi

Applicant Clariance

K-Number K200919

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KPS 2021-04-12

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

Applicant Mcgovern Medical School

K-Number K202679

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OTN 2021-04-12

Athena Surgical RMUS System

Applicant Athena Surgical, LLC

K-Number K210087

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CAW 2021-04-12

Invacare Platinum 5NXG Oxygen Concentrator

Applicant Invacare Corporation

K-Number K203210

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