41 results · 27ms · Sources: EU EUDAMED, US FDA

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BD MAX CT/GC/TV 20-Day QC Panel

FDA 510(k)
FDA Class 2 ·Microbiology

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INFINITI CYP2C19 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

PALMAZ GENESIS 29MM BILIARY

FDA Adverse Event
Death ·CORDIS CORPORATION·Product code FGE·June 21, 2013

TENDRIL ST

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·July 27, 2011

ISD-OCO BIOMEDICAL INC. DENTAL IMPLANT

FDA Adverse Event
Other ·OCO BIOMEDICAL, INC.·Product code DZE·September 30, 2008

FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

FDA Adverse Event
Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2024

VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 5, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023

VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022

CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2020

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2023

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·February 11, 2025