11 results
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8ms
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Sources: EU EUDAMED, US FDA
4.5 mm Malleolar Screw Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022