9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COGNITRACE
FDA 510(k)
FDA Class 2
·Neurology
Expert
FDA UDI
C A I INDUSTRIES CORP·00807689005117·0.18x25mm acupuncture needles.
STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
FDA 510(k)
FDA Class 2
·Radiology
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code LXH·April 25, 2016
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 10, 2013
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·May 23, 2008
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·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