6 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
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
ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·September 28, 2016
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015