9 results
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7ms
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Sources: EU EUDAMED, US FDA
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
FDA Enforcement
Class III
·Completed·Iotamotion Inc·November 13, 2024
LYFO Disk
FDA Enforcement
Class III
·Completed·Microbiologics Inc·March 23, 2022
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Enforcement
Class III
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Enforcement
Class III
·Completed·Hamilton Medical AG·July 20, 2022
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025