9 results
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28ms
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Sources: EU EUDAMED, US FDA
cobas liat CT/NG nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
Disposable Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Microlyte Ag
FDA 510(k)
FDA Unclassified
·Unknown
VITALITY 2 DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 19, 2011
GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 30, 2013
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·February 13, 2019
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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