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

GEX 2020-03-10

Bare: 808

Applicant Luvo Medical Technologies, Inc.

K-Number K193446

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PGW 2020-03-10

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

Applicant Fiagon GmbH

K-Number K200041

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OZE 2020-03-10

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

Applicant Centers for Disease Control and Prevention

K-Number K200370

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KGO 2020-03-10

JR.MEDIK Latex Surgeon’s Gloves Powder Free

Applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K-Number K192328

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GEX 2020-03-10

Rapid Acoustic Pulse Device

Applicant Soliton, Inc.

K-Number K200331

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IZF 2020-03-09

DR 600 with Tomosynthesis

Applicant Agfa N.V.

K-Number K193262

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MPN 2020-03-09

LiquiBand Plus

Applicant Advanced Medical Solutions Limited

K-Number K183570

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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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