Midmark Corporation
FDA Regulatory Profile
Midmark Corporation appears in FDA public data with 2 recalls, 6 510(k) clearances, 9 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-3013-2026, Class II) was initiated on July 20, 2026. Its most recent 510(k) clearance was granted on June 12, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3013-2026 | Class II | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg | July 20, 2026 |
| Z-3012-2026 | Class II | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark I | July 20, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | June 12, 2026 |
| K251626 | Midmark Dental Delivery System | November 3, 2025 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | April 4, 2024 |
| K201667 | Midmark Extraoral Imaging System (EOIS) | August 6, 2020 |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic | August 31, 2017 |
| K161909 | IQvitals Zone | November 17, 2016 |