9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PHADEBAS RAST TEST -ALLERGEN DISCS
FDA 510(k)
FDA Class 2
·Immunology
POLYURETHANE THERMAL DILUTION CATHET
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 12, 2014
SELOX JT 45
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO KG·Product code NVZ·November 2, 2012
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code FGE·September 27, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021