8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBI VERTEBROPLASTY SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
RMO
FDA UDI
Rmo, Inc.·00885797099686·MAX MLR BDS ASST 100 SE ASIA
RGP MULTI-PURPOSE SOLUTION ID 100136
FDA 510(k)
FDA Class 2
·Ophthalmic
ENA SCREEN EIA KIT
FDA 510(k)
FDA Class 2
·Immunology
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·April 11, 2013
ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·ALLEZ SPINE, LLC·Product code MNI·June 11, 2008
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 15, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024