Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Braemar Manufacturing with 3 510(k) clearances and 3 device recalls. The most recent is a device recall dated Dec 18, 2024: Monitoring Service Application (MSA). Software to process, analyze, display, and report ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 18, 2024 | Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible Class I · Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed d | Device recalls |
| Jan 22, 2020 | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx OnlyClass II · An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the r | Device recalls |
| Jan 22, 2020 | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx OnlyClass II · An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the r | Device recalls |
| Jan 4, 2018 | ePatchK171410 · DSH | 510(k) clearances |
| Jul 22, 2016 | Braemar Telemetry Patch SystemK153473 · DSI | 510(k) clearances |
| Oct 16, 2013 | BRAEMAR CARDIOKEY HOLTER RECORDERK130294 · MWJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
