22 results · 20ms · Sources: EU EUDAMED, US FDA

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BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML

FDA 510(k)
FDA Class 2 ·Microbiology

BD PHOENIX¿ SMIC-101

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

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

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 10, 2013

SCREW-IN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

PULMONETIC

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC·Product code CBK·May 22, 2008

CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES CORP.·Product code HBF·January 20, 2005

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018