STRATASYS LTD
FDA Regulatory Profile
STRATASYS LTD appears in FDA public data with 5 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2091-2025, Class III) was initiated on January 19, 2024. Its most recent 510(k) clearance was granted on July 7, 2022.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2091-2025 | Class III | TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fab | January 19, 2024 |
| Z-2094-2025 | Class III | TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fab | January 19, 2024 |
| Z-2090-2025 | Class III | TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fa | January 19, 2024 |
| Z-2093-2025 | Class III | TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fa | January 19, 2024 |
| Z-2092-2025 | Class III | TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables f | January 19, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220771 | Stratasys TrueDent | July 7, 2022 |