11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
R&R ALSTON CARBIDE BURS
FDA 510(k)
FDA Class 1
·Dental
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VAX-D GENESIS G2 SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Injury
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 24, 2014
*
FDA Adverse Event
Malfunction
·ARTHREX·Product code HRX·August 27, 2012
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 27, 2010
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Death
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018