113 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
KIDS Mascherine chirurgiche con elastici
Device
EU MDR
·
Eu Md Class 1
·TiMask Suisse Sagl·On the market·4 countries
F-Splint-Aid
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
F-Splint-Aid Slim
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
F-Splint-Aid & Slim
Device
EU MDD
·
Eu Md Class 2a
·Polydentia SA·No longer on the market·32 countries
F-Splint-Aid
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Polydentia SA·1 device
Sonova BTE hearing aids
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Sonova AG·180 devices
F-Splint-Aid Slim
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Polydentia SA·1 device
Sonova RIC hearing aids
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Sonova AG·370 devices
Sonova ITE hearing aids
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Sonova AG·26 devices
Sonova hearing aid mobile app
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Sonova AG·4 devices
Sonova hearing aid fitting software
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Sonova AG·15 devices
F-Splint-Aid & Slim
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Polydentia SA·1 device
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
FDA Enforcement
Class II
·Ongoing·Staar Surgical AG·June 24, 2026