1,970 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Pointe Scientific, Inc.
FDA UDI
HORIBA INSTRUMENTS INCORPORATED·00811727011527·1 x 500ml
Pointe Scientific, Inc.
FDA UDI
HORIBA INSTRUMENTS INCORPORATED·00811727014511·Glucose-6-Phosphate Dehydrogenase (G6PD) Lyse. ...
cobas omni Lysis Reagent LYS)
FDA UDI
Roche Diagnostics GmbH·00875197004496·
Pointe Scientific, Inc. Gyco Lyse
FDA UDI
HORIBA INSTRUMENTS INCORPORATED·00811727014221·Lyse for the quantitative determination of Glyc...
COBAS 6800 SYSTEM
FDA Adverse Event
Injury
·ROCHE MOLECULAR SYSTEMS, INC.·Product code MZA·August 31, 2020
COBAS 6800 SYSTEM
FDA Adverse Event
Injury
·ROCHE MOLECULAR SYSTEMS, INC.·Product code MZA·August 31, 2020
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644467419·
CELL-DYN 1800 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·January 25, 2010
ID CORE XT
FDA Adverse Event
Malfunction
·PROGENIKA BIOPHARMA S.A.·Product code PEP·December 9, 2019
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644466610·
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644466627·
DXM 1040 MICROSCAN WALKAWAY
FDA Adverse Event
Death
·BECKMAN COULTER·Product code LRG·February 13, 2025
NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
FDA Enforcement
Class II
·Terminated·BIOMERIEUX - Grenoble·March 4, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 13, 2018
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·June 4, 2014
MESH SOFRADIM - PARIETEX¿ PROGRIP¿
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·November 16, 2017
UNK_PANACRYL
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 26, 2019
NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
FDA Recall
Terminated
·BIOMERIEUX Grenoble Biomerieux Institut Christophe Merieux; 5 Rue Des Berges; Cs·Product code PPM·January 10, 2020
VENTRALEX ST
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·December 11, 2025
PARIETEX
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·November 24, 2020