10 results
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36ms
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Sources: EU EUDAMED, US FDA
ENDOCERVICAL ELECTRODE # 2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXCELLITE TURBO LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
CHEMWELL, MODEL 2900
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·Product code LGW·November 2, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC·Product code OTN·April 22, 2013
ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 9, 2008
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 15, 2011
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