10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABL8X7 FLEX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERALOY SOLDER
FDA 510(k)
FDA Class 2
·Dental
STREERABLE PTCA GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 11, 2025
LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 11, 2025
LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 11, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 22, 2008
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014