9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
artegral life
FDA UDI
Merz Dental GmbH·D7091993352·anteriors; shade C2; mould UBXL
AbutmentCAD
FDA 510(k)
FDA Class 2
·Dental
HG III FIXTURE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 100MM
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code MNH·March 7, 2013
POLIDENT HYPOALLERGENIC
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·February 5, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020