113 results · 17ms · Sources: EU EUDAMED, US FDA

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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