11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECHELON Synergy MRI System
FDA 510(k)
FDA Class 2
·Radiology
SORRENTO BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
NAVIPLAN - CT Planning Software for Total Hip Replacement
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 10, 2019
RAYONE TORIC
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·July 31, 2024
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code MEQ·November 10, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 18, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
ARCOS 17X150MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024
ARCOS CON SZ C STD 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024
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