10 results
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83ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prism Safety Capsule System
FDA UDI
Prism Medical & Design·00869997000109·Safety Needle Recapper
PRISM 6 CHANNEL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MZA·December 17, 2015
PRISM 6 CHANNEL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MZA·December 17, 2015
PRISM NEXT ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MZA·November 12, 2015
P600 PORTABLE CEILING LIFT
FDA Adverse Event
Malfunction
·PRISM MEDICAL·Product code FSA·August 29, 2014
PORTABLE CONSUMER P300 W/NON-CHARGING HAND CONTROL
FDA Adverse Event
Malfunction
·PRISM MEDICAL TORONTO LOCATION·Product code FSA·August 22, 2016
HD LAPSCP,EP,5.5,0,300
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code GCJ·October 31, 2025
4K C-MNT SCP,4.0,30,167,MITEK
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code HRX·February 19, 2025
VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code LWP·March 15, 2010
CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FPA·May 15, 2017