7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
FDA 510(k)
FDA Class 2
·General Hospital
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
FDA 510(k)
FDA Class 2
·Orthopedic
METACRYL
FDA 510(k)
FDA Class 2
·Dental
ADVIA CENTAUR XP
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS·Product code JJE·November 10, 2008
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·August 8, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 17, 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