9 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RANGER IRRIGATION FLUID WARMING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609391·Mini Sprint-Brackets Roth .022" 400 Brackets 3-...
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
HTF-HEPES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·March 14, 2011
INTELECT MOBILE 2CH STIM
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code IPF·June 11, 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