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

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DROWZLE

FDA 510(k)
FDA Class 2 ·Anesthesiology

VARIAX DISTAL RADIUS PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PERCUTANEOUS INTRODUCER KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

RESTORELLE DIRECTFIX ANT

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FTL·October 15, 2014

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 24, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

AMISTEM-P COLLARED

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

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 15, 2023

AMISTEM-P COLLARED

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

VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 25, 2021

AMISTEM-P

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

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021

LINER: VERSAFITCUP DOUBLE MOBILITY HC 48/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 27, 2021

VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·August 2, 2023

STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 7, 2023

BD FACSLYRIC¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·July 28, 2023

CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 15, 2021

BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·September 2, 2019

MPACT ACETABULAR SHELL 52 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·June 22, 2021