692 results
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40ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLX·October 18, 2014
PROG II ST AIA-PACK
FDA Adverse Event
Malfunction
·TOSOH AIA, INC.·Product code JLX·December 9, 2021
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE
FDA Adverse Event
Other
·WALLAC OY·Product code JLX·December 8, 2006
IMMULITE 1000, PROGESTERONE
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JLX·June 24, 2008
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE
FDA Adverse Event
Other
·WALLAC OY, PERKINELMER LAS·Product code JLX·March 6, 2009
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JLX·February 20, 2015
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTCHCARE DIAGNOSTICS INC·Product code JLX·January 2, 2015
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica CH Analyzer Siemens Material Number (SMN): 11099440
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Recall
Open, Classified
·DRG International, Inc.·Product code JLX·September 13, 2024
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023
Radioimmunoassay, 17-Hydroxyprogesterone
FDA classification
FDA Class 1
·Radioimmunoassay, 17-Hydroxyprogesterone
JLK, INC.
FDA registration
JLK, INC.·4 products·🇰🇷 South Korea
MEDIHUB PROSTATE
FDA UDI
JLK, Inc.·08800066200626·
JLK-PWI
FDA UDI
JLK, Inc.·08800066200794·
JLK-ICH
FDA UDI
JLK, Inc.·08800066200589·
JLK-AILINK
FDA UDI
JLK, Inc.·08800066200619·
JLK-LVO
FDA UDI
JLK, Inc.·08800066200596·
JLK-SDH
FDA UDI
JLK, Inc.·08800066200602·
JLK-CTP
FDA UDI
JLK, Inc.·08800066200787·
TSUNAMI ALX
FDA UDI
KI MOBILITY, LLC·00850013379057·TSUNAMI RIGID MANUAL WHEELCHAIR