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

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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LPL 2021-04-12

Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere

Applicant Alcon Laboratories, Inc.

K-Number K210436

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JDR 2021-04-12

Ligament Staple

Applicant Medacta International S.A.

K-Number K210456

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OWB 2021-04-12

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

Applicant Canon Medical Systems Corporation

K-Number K210900

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FXX 2021-04-11

Disposable Medical Mask

Applicant Diasia Biomedical Technology Co., Ltd.

K-Number K210018

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