10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Annabella Double Breast Pump (ADO-US23-1000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
16PW - Krispy Kreme FAK - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White
ELMED
FDA UDI
ELMED INCORPORATED·00198506057830·OLD STYLE GREENBERG BLADE 4" X 1"
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277125057·Auerbach Rake Chain Retractor 6-Prong
INTRAVASCULAR ACCESS INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
MCC Para-Fix CARY BLAIR MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
BIGLIANT/FLATOW THE COMPLETE SHOULDER SOLUTION MODULAR HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·November 20, 2008
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·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