7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Symbia SPECT and SPECT/CT Systems
FDA 510(k)
FDA Class 2
·Radiology
Clear Guide SCENERGY
FDA 510(k)
FDA Class 2
·Radiology
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·November 18, 2008
DIGOXIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code KXT·September 9, 2011
GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 22, 2013
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