6 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·December 23, 2015
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
FDA Enforcement
Class II
·Terminated·Trans American Medical, Inc.·January 15, 2014
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Enforcement
Class II
·Terminated·Hologic, Inc·September 30, 2020
MOSAIQ Oncology Information System
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·October 6, 2021
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·April 14, 2021