7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BeautiCem Veneer Kit
FDA 510(k)
FDA Class 2
·Dental
SOUNDBITE HEARING SYSTEM BY SONITUS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POGO SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 20, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS, INC.·Product code KWP·July 27, 2011
Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-1817-01/50
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008