23 results
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46ms
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Sources: EU EUDAMED, US FDA
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV20011·SilkVoice catheter 70cm
SERI
FDA UDI
SOFREGEN MEDICAL INC.·B6119467909·SERI Surgical Scaffold 5cm x 15cm
SERI Contour
FDA UDI
SOFREGEN MEDICAL INC.·B611955121·SERI Contour Surgical Scaffold 10cm x 25cm
SERI
FDA UDI
SOFREGEN MEDICAL INC.·B6119467707·SERI Surgical Scaffold 15cm x 25cm
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV1002·SilkVoice Injectable Implant, 1cc Syringe, 2 each
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV2001·SilkVoice catheter 70cm
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV10021·SilkVoice Injectable Implant, 1cc Syringe, 2 each
SERI
FDA UDI
SOFREGEN MEDICAL INC.·B6119468001·SERI Surgical Scaffold 10cm x 25cm
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV30012·SilkVoice injectable implant and accessory kit.
SERI
FDA UDI
SOFREGEN MEDICAL INC.·B6119467808·SERI Surgical Scaffold 20cm x 30cm
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV1001·SilkVoice Injectable Implant, 1cc Syringe, 2 ne...
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV10011·SilkVoice Injectable Implant, 1cc Syringe, 2 ne...
SilkVoice
FDA UDI
SOFREGEN MEDICAL INC.·B611SV3001·SilkVoice injectable implant and accessory kit.
SILK VOICE
FDA Adverse Event
Injury
·SOFREGEN MEDICAL, INC.·Product code MIX·September 10, 2021
SILK VOICE
FDA Adverse Event
Injury
·SOFREGEN MEDICAL, INC.·Product code MIX·September 24, 2021
SILK VOICE INJECTABLE IMPLANT
FDA Adverse Event
Malfunction
·SOFREGEN MEDICAL INC.·Product code MIX·January 12, 2023
SERI SURGICAL SCAFFOLD
FDA Adverse Event
Injury
·SOFREGEN MEDICAL, INC.·Product code OXF·November 17, 2017
SERI SURGICAL SCAFFOLD
FDA Adverse Event
Injury
·SOFREGEN MEDICAL, INC·Product code OXF·August 17, 2017
SERI SURGICAL SCAFFOLD
FDA Adverse Event
Injury
·SOFREGEN MEDICAL, INC·Product code OXF·September 26, 2017
SILK VOICE
FDA Adverse Event
Injury
·SOFREGEN MEDICAL, INC.·Product code MIX·January 15, 2021