March 18, 2020
Company: Braemar Manufacturing, LLC Date of Enforcement Report: 3/26/2020 Class II PRODUCT Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only. Recall Number: Z-1459-2020 REASON An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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