12 results
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19ms
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Sources: EU EUDAMED, US FDA
INSURE II
FDA 510(k)
FDA Class 2
·Hematology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20609301·Arch wires Titanol Budget mand. .012"
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609301·Mini Sprint-Brackets Roth .022" 1000 Brackets
Truliant CC
FDA UDI
Exactech, Inc.·10885862626134·TRULIANT CC MODULAR FEMORAL STEM TRIAL SIZE 3 R...
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862284945·LOGIC CC FEM STEM TRIAL SIZE 3 RIGHT
LIFT VB SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
OXIMAX N-560 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·April 10, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 18, 2011
VACUTAINER BRAND NEEDLE
FDA Adverse Event
Other
·BD·Product code JKA·June 16, 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