4 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version for the blind or visually impaired, Cat. no. 3040208. Ref. no. 03040208001 with meter model no. 768.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LFR·June 22, 2006
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013