8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COULTER CLONE T11 MONOCLONAL ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
GC Initial™
FDA UDI
Gc America Inc.·15400556708610·GC Initial™ Zr-FS Opaque Dentin Mod. ODM-1, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228750471·GC Initial™ Zr-FS Opaque Dentin Mod. ODM-1, 20g
AUTO SUTURE TITANIUM SURGICAL STAPLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEPHROSTOMY GUIDEWIRE SHEATH
FDA 510(k)
FDA Unclassified
·Unknown
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
OVIDREL SYRINGE
FDA Adverse Event
Injury
·EMD SERONO, INC.·Product code FMF·December 11, 2012