9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIAL INSERT D.54 REPLACE CUP HOLDERS
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489417283·
ACE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GORE HELEX SEPTAL OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·November 20, 2008
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 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