10 results · 83ms · Sources: EU EUDAMED, 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 SàRL·Product code GCJ·October 31, 2025

4K C-MNT SCP,4.0,30,167,MITEK

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SàRL·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