12 results
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17ms
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Sources: EU EUDAMED, US FDA
ROSENTHAL-FRENCH NEBULIZATION DOSIMETER
FDA 510(k)
FDA Class 1
·Anesthesiology
Sphere Introducer
FDA UDI
KATENA PRODUCTS, INC.·00841668110836·CARTER SPHERE INTRODUCER
UniTip Catheter
FDA UDI
Unisensor AG·07640172971833·
DuoCem
FDA 510(k)
FDA Class 2
·Dental
SEEKER/SPARK ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Coselgi
FDA UDI
Widex A/S·05706069475814·Coselgi Melodia 15 CMe15-CIC (Dark brown ) Left...
Coselgi
FDA UDI
Widex A/S·05706069552676·Coselgi Melodia 15 CMe15-CIC (Dark brown ) Left...
Coselgi
FDA UDI
Widex A/S·05706069475807·Coselgi Melodia 15 CMe15-CIC (Light beige ) Lef...
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·June 10, 2014
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 7, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·December 5, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012