25 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Okami Medical Inc.
FDA registration
Okami Medical Inc.·2 products·🇺🇸 United States
Okami Medical LOBO Vascular Occlusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
LOBO
FDA UDI
OKAMI MEDICAL, INC.·00850008222009·LOBO Handpiece
LOBO
FDA UDI
OKAMI MEDICAL, INC.·00850008222030·Peripheral Vascular Occluder
LOBO
FDA UDI
OKAMI MEDICAL, INC.·00850008222061·Peripheral Vascular Occluder
SENDERO
FDA UDI
OKAMI MEDICAL, INC.·00850008222085·Delivery Catheter
LOBO
FDA UDI
OKAMI MEDICAL, INC.·00850008222054·Peripheral Vascular Occluder
SENDERO
FDA UDI
OKAMI MEDICAL, INC.·00850008222078·Microcatheter
LOBO
FDA UDI
OKAMI MEDICAL, INC.·00850008222016·Peripheral Vascular Occluder
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Death
·OKAMI MEDICAL INC.·Product code KRD·December 30, 2025
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Injury
·OKAMI MEDICAL INC.·Product code KRD·October 8, 2025
LOBO VASCULAR OCCLUDER
FDA Adverse Event
Injury
·OKAMI MEDICAL INC.·Product code KRD·July 24, 2023
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·March 13, 2026
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·May 1, 2026
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·April 3, 2026
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·February 7, 2026
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·January 7, 2026
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·March 16, 2026
LOBO VASCULAR OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code KRD·March 16, 2026
SENDERO MAX DELIVERY CATHETER
FDA Adverse Event
Malfunction
·OKAMI MEDICAL INC.·Product code DQY·January 12, 2026