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