43 results
·
33ms
·
Sources: EU EUDAMED, US FDA
CHALLENGER DIRECT COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040047378·Curette Gracey DE 11/12 Long
VENTRIO
FDA UDI
Davol Inc.·00801741016462·Ventrio Hernia Patch, 15.5 cm x 25.7 cm (6.1" x...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm
CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, LTD·Product code GWM·January 8, 2016
MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, LTD·Product code GWM·January 11, 2016
STERILE SUBDERMAL NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 3, 2025
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 3, 2025
CUSA NXT CONSOLE (115-230V)
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·July 16, 2014
MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I
FDA Adverse Event
Malfunction
·INTEGRA, ANDOVER·Product code GWM·September 14, 2011
MULTI-PARAMETER MONITOR; DOMESTIC; W WAVEFORM; I
FDA Adverse Event
Malfunction
·INTEGRA, ANDOVER·Product code GWM·September 14, 2011
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025
EXCEL 36KHZ STRAIGHT HANDPIECE
FDA Adverse Event
Malfunction
·INTEGRA, ANDOVER·Product code GEI·August 17, 2011
CUSA NXT CONSOLE (115-230V)
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·June 1, 2012
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 21, 2025
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 3, 2025
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 3, 2025
SELECTOR 24 KHZ MICRO HANDPIECE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, LTD.·Product code LFL·October 18, 2010