Stratasys, Ltd.
Stratasys, Ltd. holds FDA 510(k) medical device clearance, cleared in 2022, with 5 FDA device recalls on record.
Top product codes for Stratasys, Ltd.
FDA recalls by Stratasys, Ltd.
- Z-2091-2025 — TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2094-2025 — TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2090-2025 — TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2093-2025 — TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2092-2025 — TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stratasys, Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.