Stratasys Inc.

Kiryat Gat Southern, IL

STRATASYS INC. appears in FDA device records in Kiryat Gat Southern, IL. FDA records list one 510(k) clearance, no PMA records and 3 registered establishments. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 5
Registered establishments: 3

FDA records under these names

1 name

FDA records resolved to Stratasys Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

STRATASYS LTD - Headquarterregistration

510(k) clearance history

FDA records hold 1 510(k) clearance for Stratasys Inc. in 2022.

Clearances by year, as a table

510(k) clearance decisions for Stratasys Inc., by decision year
Year	Clearances
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K220771	Stratasys TrueDent	EBI	Substantially Equivalent	2022-07-07

Registered establishments

FDA registered establishments for Stratasys Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3035364036	3035364036	STRATASYS INC.	5995 Opus Pkwy, Minnetonka, MN 55343 US	2026	No device listings on this registration
3016074824	3016074824	STRATASYS LTD	10 Habarzel st, Kiryat Gat Southern 8258310 IL	2026	EBF EBG EBI NDP PZY
3017374693	3017374693	STRATASYS LTD - Headquarter	1 Holtzman street, Rehovot Central 7670401 IL	2026	EBF EBG EBI NDP PZY

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2094-2025	TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances	Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.	Class III	2024-01-19	Completed
Z-2093-2025	TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances	Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.	Class III	2024-01-19	Completed
Z-2092-2025	TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances	Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.	Class III	2024-01-19	Completed
Z-2091-2025	TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances	Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.	Class III	2024-01-19	Completed
Z-2090-2025	TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances	Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.	Class III	2024-01-19	Completed

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain