10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zirconia Block
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707040415·DB BRACKETS 22 T-11 A+5 BH CUS L/R
Portex
FDA UDI
ICU MEDICAL, INC.·15019517084726·
ANTIMICROBIAL ALGINATE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
COGNISION EEG/EP SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CD HORIZON SOLERA 5.5/6.0
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·September 9, 2024
POLYSORB 7-0 18 VL SE-140-8 D/A
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·November 10, 2014
INSTATRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·August 17, 2011
ADVIA CENTAUR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·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