63 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Gentian AS
FDA registration
Gentian AS·1 product·🇳🇴 Norway
Gentian Cystatin C Single Use Control Low
FDA UDI
Gentian AS·07090038460115·The Gentian Cystatin C Controls are intended to...
Gentian Cystatin C Single Use Control High
FDA UDI
Gentian AS·07090038460122·The Gentian Cystatin C Controls are intended to...
Gentian Cystatin C Reagent Kit
FDA UDI
Gentian AS·07090038460061·
Gentian Cystatin C Calibrator
FDA UDI
Gentian AS·07090038460092·The Gentian Cystatin C Calibrator is intended t...
Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300)
FDA UDI
Gentian AS·17090038460013·
Gentian Cystatin C Calibrator Kit
FDA UDI
Gentian AS·07090038460108·The Gentian Cystatin C Calibrator kit is intend...
Gentian Cystatin C Reagent Beckman Coulter UDR Kit
FDA UDI
Gentian AS·17090038460051·
Gentian Cystatin C Control Kit (2 x 1mL)
FDA UDI
Gentian AS·07090038460078·The Gentian Cystatin C Controls are intended to...
Gentian Cystatin C Control Kit (2 x 1mL)
FDA UDI
Gentian AS·17090038460020·
Gentian Cystatin C Calibrator Kit
FDA UDI
Gentian AS·17090038460037·
Gentian Cystatin C Control Kit (2 x 5mL)
FDA UDI
Gentian AS·07090038460085·The Gentian Cystatin C Controls are intended to...
2939653-2018-00010
FDA Adverse Event
Injury
·June 13, 2018
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)
FDA Recall
Terminated
·Gentian AS Bjornasveien·Product code NDY·September 2, 2020
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)
FDA Enforcement
Class II
·Terminated·Gentian AS·October 21, 2020
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·March 9, 2020
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·March 22, 2013
DEROYAL SKIN MARKER
FDA Adverse Event
Other
·DEROYAL INDUSTRIES, INC.·Product code FZZ·December 3, 2010
PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG
FDA Adverse Event
Injury
·MEDELA INC.·Product code HGX·November 5, 2013
PHONAK LYRIC 4
FDA Adverse Event
Injury
·SONOVA AG·Product code ESD·July 11, 2025