23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Netherlands
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Time Timer Twist - Lake Day Blue
Device
EU MDR
·
Eu Md Class 1
·Robo Educational Toys B.V.·On the market
Time Timer MOD Home Edition - Lake Day Blue
Device
EU MDR
·
Eu Md Class 1
·Robo Educational Toys B.V.·On the market
Willingsford NL
Manufacturer
🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy
Dayes BV
Importer
🇳🇱 Netherlands
Time Timer Twist - Lake Day Blue
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Robo Educational Toys B.V.·1 device
Dayes Europe B.V.
Importer
🇳🇱 Netherlands·8 Manufacturers
Time Timer MOD Home Edition - Lake Day Blue
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Robo Educational Toys B.V.·1 device
Aprobaxil
Device
EU MDD
·
Eu Md Class 2a
·Willingsford NL·On the market·7 countries
Acapsil
Device
EU MDD
·
Eu Md Class 2a
·Willingsford NL·On the market·7 countries
Amicapsil-SCI
Device
EU MDD
·
Eu Md Class 2b
·Willingsford NL·On the market·6 countries
Amicapsil
Device
EU MDD
·
Eu Md Class 2b
·Willingsford NL·On the market·8 countries
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Aprobaxil 750 mg
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Willingsford NL·1 device
Acapsil 750 mg
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Willingsford NL·1 device
Amicapsil-SCI
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Willingsford NL·1 device
Amicapsil 750 mg
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Willingsford NL·1 device
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
THTR-02-L14
Certificate
MDD Annex II Section 4·Willingsford NL·Eurofins Electric & Electronics Finland Oy·4 Basic UDI-DIs