12 results
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18ms
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Sources: EU EUDAMED, US FDA
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHETIC GLASS BONE GRAFT MATERIAL
FDA 510(k)
FDA Class 2
·Dental
LIGASURE IMPACT THORACIC
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·March 27, 2013
GENERATOR EPT-1000XP REFURBISHED
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC, EP TECHNOLOGIES·Product code LPB·June 13, 2008
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 8, 2011
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023
UNKNOWN - MAXON
FDA Adverse Event
Injury
·DAVIS & GECK CARIBE LTD·Product code GAM·October 5, 2022
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 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
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