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

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DIADEXUS PLAC TEST

FDA 510(k)
FDA Class 2 ·Immunology

MDI DS-DNA TEST

FDA 510(k)
FDA Class 2 ·Immunology

AUTO-LOCK

FDA 510(k)
FDA Class 2 ·General Hospital

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 2, 2013

BIPOL LEAD MODEL 300

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·March 9, 2011

AED PRO

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 16, 2008

PEN NEEDLE 31GX5MM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FMI·December 12, 2018

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

FDA Enforcement
Class II ·Terminated·Carestream Health, Inc.·January 29, 2014

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·July 23, 2025

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025