352 results
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57ms
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Sources: EU EUDAMED, US FDA
5-PLASMA Bivalirudin Control
FDA UDI
5-Diagnostics Ltd·05070002420385·Human plasma-based control material intended fo...
5-PLASMA Bivalirudin AMR Verification Kit
FDA UDI
5-Diagnostics Ltd·05070002420378·The 5-PLASMA Bivalirudin AMR Verification Kit i...
5-PLASMA Bivalirudin Calibrator
FDA UDI
5-Diagnostics Ltd·05070002420392·Human plasma-based calibrator material intended...
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·February 8, 2002
BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 27, 2020
BD PEN NEEDLE 32GX4MM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FMI·December 17, 2020
EVIS LUCERA ELITE DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·December 12, 2023
BIOPSY FORCEPS
FDA Adverse Event
Injury
·AOMORI OLYMPUS CO., LTD.·Product code FCL·December 12, 2023
SINGLE USE 3-LUMEN SPHINCTEROTOME V
FDA Adverse Event
Injury
·AOMORI OLYMPUS CO., LTD.·Product code KNS·December 12, 2023
EVIS LUCERA DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·December 11, 2023
EVIS DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·December 12, 2023
BD¿ STEM CELL ENUMERATION
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·December 12, 2023
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·October 8, 2021
ID NOW COVID 19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 24, 2022
UNKNOWN PROGRIP MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·June 24, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 1, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 24, 2022
EVIS LUCERA ELITE COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·December 18, 2023
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 21, 2019
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.
FDA Enforcement
Class III
·Terminated·Remel Inc·August 21, 2013