11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPIFLO®
FDA UDI
Ogenix·00855526003055·Transdermal Continuous O2 Therapy. Oxygen Conc...
EPIFLO®
FDA UDI
Ogenix·00855526003079·Transdermal Continuous O2 Therapy Oxygen Concen...
EPIFLO® oxygen delivery cannula
FDA UDI
Ogenix·00855526003024·Oxygen delivery cannula for use with EPIFLO dev...
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·April 16, 2012
Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·March 24, 2006
SUMAVEL DOSEPRO SD/IJ 0.5ML 1 - 6MG
FDA Adverse Event
Malfunction
·ZOGENIX·Product code FMF·October 20, 2011
SUMAVEL DOSEPRO 6 MG
FDA Adverse Event
Malfunction
·ZOGENIX·Product code KZE·May 11, 2011
SUMAVEL DOSEPRO
FDA Adverse Event
Injury
·ZOGENIX·Product code KZE·July 5, 2010
LYME TESTS
FDA Adverse Event
Injury
·Product code LSR·September 7, 2014
PEDIGUARD
FDA Adverse Event
Malfunction
·ORGENIX, LLC·Product code PDQ·September 1, 2016
PEDIGUARD
FDA Adverse Event
Malfunction
·SPINEGUARD SA -ORGENIX LLC·Product code FZX·August 10, 2010