16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GC INITIAL MC, AL AND LF
FDA 510(k)
FDA Class 2
·Dental
ULTRASOUND SCANNER TYPE 2102
FDA 510(k)
FDA Class 2
·Radiology
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
ETEST FLUCONAZOLE FL 256 WW S30
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code NGZ·May 7, 2021
BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·March 12, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·May 9, 2008
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