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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIO Corporation
FDA registration
DIO Corporation·18 products·🇰🇷 South Korea
DIO IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO SM IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO-LIGHT LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUBEAM, SUPER NOVA, DIO
FDA 510(k)
FDA Class 2
·Physical Medicine
DIO PROTEM IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO CAD/CAM Abutment
FDA 510(k)
FDA Class 2
·Dental
DIO PROTEM IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO BIOTITE-H IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO STEADY EXTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO-LIGHT 60 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 12, 2019
DIO PTR +24V INTRAOCULAR LENS, DIO PTR +24V
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·November 8, 2023
DIO-DENT 10 DENTAL DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SM IMPLANT SYSTEM
FDA Adverse Event
Other
·DIO CORP.·Product code DZE·May 28, 2013
SM IMPLANT SYSTEM
FDA Adverse Event
Other
·DIO CORP.·Product code DZE·May 28, 2013
DIO PLATE AND SCREWS
FDA Adverse Event
Injury
·DIO MEDICAL·Product code MNH·October 5, 2016
UF IMPLANT SYSTEM
FDA Adverse Event
Other
·DIO CORPORATION·Product code DZE·August 19, 2013
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIO IDx Instrument
FDA UDI
Osstell AB·09010522001141·ISQ Measurement Instrument