8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LYRIS MODULAR INFO SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102213·ENDOTHELIAL STRIPPER
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SAFEPRO PLUS SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
TRAUMACEM V+ CEMENT KIT 10 ML
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code MQV·May 27, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 9, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·September 8, 2010
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