9 results
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20ms
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Sources: EU EUDAMED, US FDA
SNAP II EEG MONITOR
FDA 510(k)
FDA Class 2
·Neurology
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609971·BioQuick-Brackets Roth .022" 100 Brackets 3-5 w...
ZORTRAN DETECTOR
FDA 510(k)
FDA Class 2
·General Hospital
PAM-RL
FDA 510(k)
FDA Class 2
·Neurology
T25 STARDRIVE SHAFT F/MATRIX LONG
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 16, 2013
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 1, 2011
MICROCHOICE ELITE HIGH SPEED DRILL
FDA Adverse Event
Malfunction
·CONMED LINVATEC·Product code DZI·June 12, 2008
Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011
Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011