10 results
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25ms
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Sources: EU EUDAMED, US FDA
IDS-iSYS Total Testosterone
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Action Trackchair Hawk
FDA 510(k)
FDA Class 2
·Physical Medicine
BD PYXIS¿ MEDBANK TOWER
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·January 7, 2026
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·September 9, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 29, 2013
SYRINGE 3ML LL W/BLUNT PLASTIC CANN
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·May 10, 2021
CANNULA BLUNT PLASTIC
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 5, 2021
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014