11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uCT 550
FDA 510(k)
FDA Class 2
·Radiology
ONE TOUCH BASIC ENHANCED
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 23, 2002
SIEMENS ENHANCED IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Temno Elite Biopsy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIGITALDIAGNOST C90 HIGHPERFORMANCE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·June 17, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 20, 2008
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 17, 2011
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·July 22, 2013
ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·March 2, 2026
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