9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Accelerate Arc System
FDA 510(k)
FDA Class 2
·Microbiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017996·K-Wire, Single Ended, Trocar Point, Diameter Si...
WEST NILE VIRUS IGM CAPTURE ELISA
FDA 510(k)
FDA Class 2
·Microbiology
INTRA-OPERATIVE ULTRASOUND TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Other
·STAAR SURGICAL CO·Product code MTA·November 6, 2008
LIFESTENT BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·August 5, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 16, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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