411 results
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15ms
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Sources: EU EUDAMED, US FDA
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
FDA Enforcement
Class II
·Completed·Shimadzu Medical Systems·July 22, 2020
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
FDA Enforcement
Class II
·Completed·Siemens Medical Solutions USA, Inc·July 4, 2018
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
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
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
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
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Enforcement
Class III
·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
FDA Enforcement
Class II
·Completed·Beckman Coulter, Inc.·July 23, 2025
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·July 10, 2024
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Enforcement
Class II
·Completed·ESAOTE S.P.A.·March 11, 2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
FDA Enforcement
Class II
·Completed·Philips Ultrasound, LLC·January 7, 2026
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023