7 results
·
81ms
·
Sources: EU EUDAMED, US FDA
EBI PATIENT CARE, INC.
FDA registration
EBI PATIENT CARE, INC.·2 products·🇺🇸 United States
SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
FDA Adverse Event
Injury
·EBI PATIENT CARE, INC.·Product code LOE·December 23, 2025
EBI SPF-PLUS 60/M
FDA Adverse Event
Malfunction
·EBI PATIENT CARE, INC.·Product code LOE·November 29, 2011
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Recall
Terminated
·EBI Patient Care, Inc.·Product code LOE·April 20, 2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Recall
Terminated
·EBI Patient Care, Inc.·Product code LOE·April 20, 2017
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017