8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTELLISYSTEM II COLOR MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral life
FDA UDI
Merz Dental GmbH·D7091993341·anteriors; shade C2; mould BIM
iCTmotor (WL-1)
FDA 510(k)
FDA Class 1
·Dental
CENTURY MODEL 105C
FDA 510(k)
FDA Class 1
·Dental
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·March 7, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FNL·January 21, 2011
VIVA XT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·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