8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-ASSAY APO B
FDA 510(k)
FDA Class 2
·Immunology
artegral life
FDA UDI
Merz Dental GmbH·D7091993354·anteriors; shade C2; mould UBM
Air Compression Therapy Device
FDA 510(k)
FDA Class 2
·Physical Medicine
KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A
FDA 510(k)
FDA Class 2
·Radiology
TRIMA ACCEL
FDA Adverse Event
TERUMO BCT·Product code GKT·March 7, 2013
SUPER POLIGRIP
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOT·February 5, 2011
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·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