468 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
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Eu Md Class 2a
·HCI Solutions AG·Not intended for eu market
MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
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Eu Md Class 2a
·b-rayZ AG·On the market·10 countries
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDR
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Eu Md Class 1
·CODONIS AG·On the market
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDR
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Eu Md Class 1
·CODONIS AG·On the market
MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
Device
EU MDR
·
Eu Md Class 1
·QUMEA AG·On the market
DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER
Device
EU MDR
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Eu Md Class 1
·macu4 AG·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
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
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
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
FDA Enforcement
Class II
·Ongoing·SPINEART SA·August 20, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
FDA Enforcement
Class II
·Ongoing·SPINEART SA·August 20, 2025
Biosensors Europe SA
Manufacturer
🇨🇭 Switzerland·185 Basic UDI-DIs·185 Devices·1 Importer·National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., National Standards Authority of Ireland (NSAI), DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.
Advanced Osteotomy Tools - AOT AG
Manufacturer
🇨🇭 Switzerland·TUV Rheinland Italia SRL
Advanced Osteotomy Tools - AOT AG
Manufacturer
🇨🇭 Switzerland
Ventilator HAMILTON-C6, PN: 160021
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·June 26, 2024
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
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