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

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BIOPLANT

FDA 510(k)
FDA Class 2 ·Dental

EMIT 2000 GENTAMICIN PLUS ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

FDA 510(k)
FDA Class 3 ·Cardiovascular

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

FATHOM GUIDEWIRE

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011

BASIS¿ SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012

CARELINK

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code DXY·April 10, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

EPIC PLUS VR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026