Leltek, Inc.
Leltek, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent 510(k) clearance was granted on May 8, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging | May 8, 2025 |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System ( | September 11, 2024 |
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | October 25, 2022 |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | November 3, 2021 |
| K191235 | Leltek Ultrasound Imaging System | February 12, 2020 |