12 results
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48ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAMI RRT Cassette
FDA UDI
Dialco Medical Inc·B815SA400000·The SAMI RRT Cassette is provided sterile, sing...
DIMI RRT System
FDA UDI
Dialco Medical Inc·B815DM850000·The DIMI RRT System is a software controlled de...
SAMI RRT
FDA UDI
Dialco Medical Inc·B815SA100010·The SAMI RRT Unit is a software controlled devi...
SAMI RRT System
FDA UDI
Dialco Medical Inc·B815SM1000030·The SAMI RRT Unit is a software controlled devi...
DIMI RRT Cassette
FDA UDI
Dialco Medical Inc·B815DI400000·The DIMI RRT Cassette is provided sterile, sing...
SAMI Hemofiltration Cassette
FDA UDI
Dialco Medical Inc·B815SM2000030·The SAMI Hemofiltration Cassette is provided st...
SAMI Hemofiltration Cassette
FDA UDI
Dialco Medical Inc·B815SA300000·The SAMI Hemofiltration Cassette is provided st...
INPEN MMT-105NNBLNA NOVO NORDISK BLUE
FDA Adverse Event
Malfunction
·COMPANION MEDICAL INC·Product code FMF·June 1, 2021
INPEN MMT-105ELBLNA ELI LILY BLUE
FDA Adverse Event
Malfunction
·COMPANION MEDICAL INC·Product code FMF·March 7, 2022
INPEN MMT-105NNPKNA NOVO NORDISK PINK
FDA Adverse Event
Malfunction
·COMPANION MEDICAL INC·Product code FMF·January 13, 2023
INPEN MMT-105NNBLNA NOVO NORDISK BLUE
FDA Adverse Event
Malfunction
·COMPANION MEDICAL INC·Product code FMF·October 4, 2022
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
FDA Recall
Terminated
·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014