468 results · 32ms · Sources: EU EUDAMED, US FDA

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MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Device
EU MDR · Eu Md Class 2a ·HCI Solutions AG·Not intended for eu market

MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Device
EU MDR · Eu Md Class 2a ·b-rayZ AG·On the market·10 countries

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device
EU MDR · Eu Md Class 1 ·CODONIS AG·On the market

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device
EU MDR · 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 · Eu Md Class 1 ·macu4 AG·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 · 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