Micromed S.p.A.
FDA Regulatory Profile
Micromed S.p.A. appears in FDA public data with 1 recall, 7 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2353-2026, Class II) was initiated on May 4, 2026. Its most recent 510(k) clearance was granted on September 23, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2353-2026 | Class II | SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firm | May 4, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211974 | LED PHOTIC System | September 23, 2021 |
| K180761 | SD LTM STIM Cortical Stimulator | June 18, 2018 |
| K171384 | Micromed BRAIN QUICK system | February 1, 2018 |
| K071782 | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | January 10, 2008 |
| K914762 | MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR | December 5, 1991 |
| K882980 | REBUILDER BUCKET SYSTEM | April 24, 1989 |
| K874085 | REBUILDER(TM) | December 11, 1987 |