7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
AIM
FDA 510(k)
FDA Class 2
·Radiology
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRILOGY SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER·Product code LPH·January 9, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015