14 results · 23ms · Sources: EU EUDAMED, US FDA

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TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NANOCERAM- BRIGHT

FDA 510(k)
FDA Class 2 ·Dental

MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 19, 2022

SYMBIQ DCHANNEL 3.01

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 9, 2014

TRILOGY 200

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code CBK·June 5, 2013

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 24, 2011

FLEXOR URETERAL ACCESS SHEATH AND DILATORS

FDA Adverse Event
Malfunction ·COOK INC·Product code FED·January 3, 2020

FLEXOR URETERAL ACCESS SHEATH AND DILATORS

FDA Adverse Event
Malfunction ·COOK INC·Product code FED·January 2, 2020

FLEXOR URETERAL ACCESS SHEATH AND DILATORS

FDA Adverse Event
Malfunction ·COOK INC·Product code FED·January 7, 2020

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 15, 2023

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·June 28, 2023

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

IPSOGEN JAK2 PCR KIT IVD

FDA Adverse Event
QIAGEN GMBH·Product code PSU·September 4, 2018