40 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·May 20, 2026
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
FDA Enforcement
Class II
·Ongoing·Hologic, Inc.·March 1, 2023
FlexLab (FLX); Version: FLX-217-10;
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·December 3, 2025
FlexLab (FLX); Version: FLX-217-40;
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·December 3, 2025
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
FDA Enforcement
Class II
·Ongoing·TERRAGENE S.A.·March 5, 2025
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
Sedecal NOVA FA DR System. for diagnostic radiography.
FDA Enforcement
Class II
·Ongoing·Sedecal S.A.·November 28, 2018
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 13, 2020
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·June 10, 2020
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 13, 2020
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 13, 2020
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·June 10, 2020
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·June 10, 2020
biokitHSV-2 Rapid Test, REF: 300028001
FDA Enforcement
Class II
·Ongoing·Biokit, S.A.·February 1, 2023
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 20, 2021
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023