43 results · 33ms · Sources: EU EUDAMED, US FDA

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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