166 results · 28ms · Sources: EU EUDAMED, US FDA

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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