21 results · 24ms · Sources: EU EUDAMED, US FDA

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Saige-Dx

FDA 510(k)
FDA Class 2 ·Radiology

RHINOGUARD

FDA 510(k)
FDA Class 2 ·Anesthesiology

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 20, 2024

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

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·November 10, 2014

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KOG·September 9, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·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

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

VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026