21 results
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19ms
·
Sources: EU EUDAMED, US FDA
VOLU-SOL GILLS EA
FDA 510(k)
FDA Class 1
·Hematology
Traverse
FDA UDI
Nuvasive, Inc.·00887517153982·Traverse Plate, 35mm 2 Bolt
75V - Class A BMD 21 - 3 Shelf Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620350·75V - Class A BMD 21 - 3 Shelf Cabinet
HEPAFAT SCAN
FDA 510(k)
FDA Class 2
·Radiology
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
FDA 510(k)
FDA Class 2
·Dental
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247298·C-T Ti TRANSITION ROD, 3.5mm - 5.5mm X 500mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247304·C-T Ti TRANSITION ROD, 3.5mm - 6.0mm X 200mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376549798·C-T Ti Transition Rod, 3.5mm - 6.0mm x 600mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247311·C-T Ti TRANSITION ROD, 3.5mm - 6.0mm X 300mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247335·C-T Ti TRANSITION ROD, 3.5mm - 6.0mm X 500mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247281·C-T Ti Transition Rod, 3.5mm - 5.5mm X 400mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247267·C-T Ti TRANSITION ROD, 3.5mm - 5.5mm X 200mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247274·C-T Ti TRANSITION ROD, 3.5mm - 5.5mm X 300mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376247328·C-T Ti TRANSITION ROD, 3.5mm - 6.0mm X 400mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376549781·C-T Ti Transition Rod, 3.5mm - 5.5mm x 600mm
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
TC SPO2RT
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 9, 2012
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·August 26, 2010
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 23, 2026
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015