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

NHA 2020-03-09

Pre-Milled Blank

Applicant Arum Dentistry Co., Ltd.

K-Number K193425

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MAX 2020-03-09

MectaLIF Anterior Simple

Applicant Medacta International S.A.

K-Number K200048

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MNT 2020-03-09

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

Applicant Fisher & Paykel Healthcare Limited

K-Number K191624

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DYB 2020-03-09

Edwards eSheath Introducer Set

Applicant Edwards Lifesciences

K-Number K200258

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LNH 2020-03-09

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K192574

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NAY 2020-03-09

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K200049

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OEB 2020-03-09

syngo.CT Lung CAD

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K193216

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GEX 2020-03-09

Elite iQ

Applicant Cynosure, LLC

K-Number K193426

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PRI 2020-03-09

Elecsys BRAHMS PCT

Applicant Roche Diagnostics

K-Number K192815

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QBP 2020-03-06

SwabTip Male Disinfectant Cap

Applicant Icu Medical

K-Number K190918

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HTY 2020-03-06

OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant

Applicant OSSIO , Ltd.

K-Number K190652

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DBF 2020-03-06

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

Applicant HORIBA ABX SAS

K-Number K191562

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