180 results · 24ms · Sources: EU EUDAMED, US FDA

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APTUS HELI-FX AORTIC SECUREMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

LYMPHA PRESS 201MAX, MODEL 201MAX

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE

FDA 510(k)
FDA Class 2 ·Microbiology

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 24, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

MULTIDIAGNOST ELEVA

FDA Adverse Event
Injury ·PHILIPS HEALTHCARE·Product code IZI·June 14, 2011

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

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

FDA Enforcement
Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

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

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

FDA Recall
Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

DORMA 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

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