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

MUH 2021-07-22

DC-Air and Athlos-1 and Athlos-Air

Applicant Athlos OY

K-Number K211688

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MXD 2021-07-22

Reveal LINQ Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K212008

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OLP 2021-07-22

DemarkQ WOW, DemarkQ POP

Applicant Shenzhen Kaiyan Medical CO , Ltd.

K-Number K203214

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FXX 2021-07-21

Single-Use Surgical Mask Model FE2311B

Applicant Byd Precison Manufacturer Co., Ltd.

K-Number K210970

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DRG 2021-07-21

LifeSignals Multi-Parameter Remote Monitoring Platform

Applicant Lifesignals, Inc.

K-Number K202868

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PNP 2021-07-21

AbutmentCAD

Applicant Exocad GmbH

K-Number K193352

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JKA 2021-07-21

CHIRAVAC Blood Collection Needles

Applicant Chirana T. Injecta

K-Number K201009

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FMI 2021-07-21

Promisemed Insulin Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K210059

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LZA 2021-07-21

Nitrile Patient Examination Glove

Applicant Yunnan Huazhiyuan Medical Technology Co., Ltd.

K-Number K210686

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NKB 2021-07-21

CD Horizon Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K211958

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OTN 2021-07-21

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Applicant Boston Scientific Corporation

K-Number K211223

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QJF 2021-07-21

MolecuLightDX

Applicant MolecuLight, Inc.

K-Number K211901

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