Braemar Manufacturing, LLC
Braemar Manufacturing, LLC appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 3 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0708-2025, Class I) was initiated on December 18, 2024. Its most recent 510(k) clearance was granted on January 4, 2018.
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 3
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0708-2025 | Class I | Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac even | December 18, 2024 |
| Z-1460-2020 | Class II | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 551 | January 22, 2020 |
| Z-1459-2020 | Class II | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 551 | January 22, 2020 |