9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sealer Solvent
FDA 510(k)
FDA Unclassified
·Unknown
Portex
FDA UDI
ICU MEDICAL, INC.·15019517075922·
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
FDA 510(k)
FDA Class 2
·Immunology
NAVAJO PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 29, 2024
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·November 10, 2014
INSTATRAK 3500
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·August 17, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·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