98 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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Valentis AG
Manufacturer
🇨🇭 Switzerland
LiNA Medical AG
Manufacturer
🇨🇭 Switzerland
BIOPTRON AG
Manufacturer
🇨🇭 Switzerland
Rontis Corporation SA
Manufacturer
🇨🇭 Switzerland·225 Basic UDI-DIs·443 Devices·TÜV NORD CERT GmbH, TÜV NORD CERT GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., TUV NORD Polska Sp. z o.o, TUV NORD Polska Sp. z o.o, and TUV NORD Polska Sp. z o.o
NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
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Eu Md Class 1
·Rontis Corporation SA·On the market
NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
·
Eu Md Class 1
·Rontis Corporation SA·On the market
NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
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Eu Md Class 1
·Rontis Corporation SA·On the market
Nasalou - Nasal Aspirator Refills X 24
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Rontis Corporation SA·1 device
Nasalou - Nasal Aspirator Refills X 12
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Rontis Corporation SA·1 device
Nasalou - Nasal Aspirator Starter Kit
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Rontis Corporation SA·1 device
TNP/MDD/0389/51842021
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI
TNP/MDD/0389/5184/2021
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI
TNP/MDD/0389/5784/2021
Certificate
MDD Annex II (excluding section 4)·Rontis Corporation SA·TUV NORD Polska Sp. z o.o·1 Basic UDI-DI
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
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
FDA Enforcement
Class II
·Ongoing·Medartis AG·June 17, 2026
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
FDA Enforcement
Class II
·Ongoing·Medartis AG·March 18, 2026
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
FDA Enforcement
Class II
·Ongoing·Medartis AG·March 18, 2026
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
FDA Enforcement
Class II
·Ongoing·Staar Surgical AG·March 11, 2026
FlexLab (FLX); Version: FLX-217-10;
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·December 3, 2025
FlexLab (FLX); Version: FLX-217-40;
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·December 3, 2025