9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFIT GREEN POWDER FREE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SwishTapered™ Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106470·4.8mmD x 12mmL, 4.8mmD Platform
COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE
FDA 510(k)
FDA Class 2
·Dental
K-CAP-E, STERILE
FDA 510(k)
FDA Class 2
·Orthopedic
BIT, DRILL
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTW·November 25, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 30, 2013
SILICONE FLAT FULL-FLUTED CHANNEL DRAIN
FDA Adverse Event
Malfunction
·BARD·Product code GCY·December 3, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 4, 2014
SwishTapered Implant Intended for use in support for fixed bridgework.
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·March 28, 2018