17 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Netherlands
×
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
Dayes BV
Importer
🇳🇱 Netherlands
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
Dayes Europe B.V.
Importer
🇳🇱 Netherlands·8 Manufacturers
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
20M00105CRT01
Certificate
MDD Annex II (excluding section 4)·NICo-Lab B.V.·Kiwa Dare B.V.·1 Basic UDI-DI
BD Kiestra" ReadA; Catalog No.: 446948.
FDA Enforcement
Class II
·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026
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
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
ABG Lab Europe B.V.
Authorized representative
🇳🇱 Netherlands
Synga medical b.v.
Importer
🇳🇱 Netherlands·10 Manufacturers
AnalytiChem Netherlands B.V.
Importer
🇳🇱 Netherlands·11 Manufacturers
Biomet Global Supply Chain Center B.V.
Importer
🇳🇱 Netherlands·18 Manufacturers
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices