13 results
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21ms
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Sources: EU EUDAMED, US FDA
Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
K-WIRE D1MM L70MM
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489537196·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688415530·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688407344·
Portex
FDA UDI
ICU MEDICAL, INC.·15019315060267·
IntraSight Mobile
FDA 510(k)
FDA Class 2
·Radiology
LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2025
LIVIAN RF HE - IS-1/DF-1/LV-1
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
RENAISSANCE 29 P-WASH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·August 10, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 30, 2013
ACCOLADE DR SL MRI (Model L311)
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