10 results
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18ms
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Sources: EU EUDAMED, US FDA
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)
FDA 510(k)
FDA Unclassified
·Unknown
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496060963·MICROMASSAGE COMFORT, SIZE S, NERO, GRADUATED C...
STA-LIATEST FREE PROTEIN S TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
DA VINCHI EEG AND EMG/EP SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
PRIME ZOOM STRETCHER,30"LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·April 16, 2013
TRILOGY LINER INSERTER - MECHANICAL
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·March 14, 2011
ASCENSIA BREEZE2 TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·June 13, 2008
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