51 results · 28ms · Sources: EU EUDAMED, US FDA

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Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113479·MINIATURE BLADE #64 (BX/5)

Vital Sign Monitoring Sensor (Model :XK300)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM

EQUILASE SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SMITH & NEPHEW OFF-CENTERED PORP

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·May 20, 2024

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code JJE·March 2, 2020

ARCHITECT C4000 ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·April 22, 2015

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 2, 2022

ARCHITECT C16000 PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 30, 2025

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·January 16, 2023

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 6, 2025

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·December 9, 2016

VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code JJE·August 7, 2020

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code JJE·August 19, 2021

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 21, 2023

1628664-2017-00061

FDA Adverse Event
Malfunction ·March 8, 2017

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 24, 2025