11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEMOSIL PT-FIBRINOGEN HS PLUS
FDA 510(k)
FDA Class 2
·Hematology
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609311·Mini Sprint-Brackets Roth .022" 20 Brackets 3 w...
BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·July 8, 2019
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AU5 ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TIGER SPINE SYSTEM
FDA Adverse Event
Malfunction
·CORELINK, LLC.·Product code MNH·April 10, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011
HEMOLOK LIGATING CLIP
FDA Adverse Event
Other
·TELEFLEX MEDICAL·Product code GDO·June 12, 2008
BIODESIGN URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTM·July 29, 2013
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