4 results
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24ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
FDA Enforcement
Class II
·Ongoing·Devicor Medical Products Inc·June 3, 2026
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
FDA Enforcement
Class II
·Terminated·Devicor Medical Products Inc·March 29, 2017
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
FDA Enforcement
Class II
·Terminated·Devicor Medical Products Inc·July 20, 2016
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Enforcement
Class II
·Terminated·Devicor Medical Products Inc·June 1, 2022