8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12
FDA 510(k)
FDA Class 2
·Radiology
ENDOBUTTON
FDA UDI
Smith & Nephew, Inc.·00885554006650·MTO GUAGE DEPTH ENDOBUTTON 30MM TO 180MM
XYLOS POROUS SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
FDA 510(k)
FDA Class 2
·Immunology
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code DHA·June 27, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 9, 2010
WECK VISISTAT 35W 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·December 12, 2012
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020