9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fit SA
FDA 510(k)
FDA Class 2
·Dental
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583030128·ENCHANT 100 B 105 FW 1.0
AWBAT-S, AWBAT-D, AWBAT-M
FDA 510(k)
FDA Unclassified
·Unknown
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
FDA 510(k)
FDA Class 1
·Dental
ASCENT SYSTEM-BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016
OVATIO
FDA Adverse Event
Malfunction
·SORIN CRM·Product code MRM·July 8, 2011
6000CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 11, 2013
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·October 17, 2014
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