8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ULTRABUR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
FDA 510(k)
FDA Class 1
·Microbiology
STARCAM 4000
FDA 510(k)
FDA Class 1
·Radiology
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·February 12, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·August 1, 2014
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015
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