10 results
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20ms
·
Sources: EU EUDAMED, US FDA
IVENA VASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
APNOESCREEN PRO, ALPHA SCREEN PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
C. NET 2100
FDA 510(k)
FDA Class 2
·Cardiovascular
21G 1IN NEEDLE
FDA Adverse Event
Injury
·BD·Product code FMI·April 11, 2013
PALMAZ GENESIS OPTA PRO
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code FGE·September 4, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code CEW·April 15, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
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