22 results · 25ms · Sources: EU EUDAMED, US FDA

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E1000 Dx Digital Pathology Solution

FDA 510(k)
FDA Class 2 ·Pathology

Portex

FDA UDI
ICU MEDICAL, INC.·00351688050154·

PACSEAL PIT & FISSURE SEALANT

FDA 510(k)
FDA Class 2 ·Dental

POWERSTICK MALE LATEX CONDOMS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CONTOUR® PLUS BLUE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2025

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 30, 2026

SYNCHRO 14 GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION·Product code DQX·November 20, 2008

PROXIMATE PPH PROCEDURE SET

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 9, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026

CONTOUR® CARE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025

CONTOUR® CARE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

AMISTEM-P COLLARED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 29, 2025

BD CATHENA¿ SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022

CONTOUR® NEXT

FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025

CONTOUR® PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025

DM CONVERTER ¿ TIN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2026

MECTACER BIOLOX OPTION HEADS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025