166 results
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28ms
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Sources: EU EUDAMED, US FDA
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Country: Norway
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GE Healthcare Vivid S60, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S70, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S70N, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S60N, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 17, 2024
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
FDA Enforcement
Class II
·Ongoing·Moller Vital·May 22, 2019
Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
FDA Enforcement
Class II
·Ongoing·Moller Vital·May 22, 2019
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 17, 2024
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)
FDA Enforcement
Class II
·Terminated·Gentian AS·October 21, 2020
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
FDA Enforcement
Class II
·Terminated·NordicNeuroLab AS·June 6, 2018
Laerdal Medical AS
Manufacturer
🇳🇴 Norway·93 Basic UDI-DIs·256 Devices·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS
Appsens AS
Manufacturer
🇳🇴 Norway·10 Basic UDI-DIs·10 Devices·DNV Product Assurance AS and DNV Product Assurance AS
Medistim ASA
Manufacturer
🇳🇴 Norway·1 Basic UDI-DI·1 Device·DNV Product Assurance AS
Saga Dental Supply AS
Manufacturer
🇳🇴 Norway·3 Basic UDI-DIs·79 Devices·DNV Product Assurance AS
Maxeta AS
Manufacturer
🇳🇴 Norway·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS
Norgesplaster AS
Manufacturer
🇳🇴 Norway·18 Basic UDI-DIs·82 Devices·DNV Product Assurance AS
ORTHODONTIC DEVICES - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Saga Dental Supply AS·On the market·1 country
Medistim L15 Imaging Ultrasound Probe
Device
EU MDD
·
Eu Md Class 3
·Medistim ASA·On the market·32 countries
Laerdal Suction Unit (LSU)
Device
EU MDD
·
Eu Md Class 2a
·Laerdal Medical AS·On the market·21 countries
DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER
Device
EU MDD
·
Eu Md Class 1
·Norgesplaster AS·On the market