9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ingenia Ambition S and Ingenia Ambition X
FDA 510(k)
FDA Class 2
·Radiology
ADVANCE A-CLASS TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 17, 2014
ENDOPATH 5MM CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 21, 2013
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·July 27, 2011
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020
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