1,293 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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iFlash-17α-OH-P
FDA UDI
Shenzhen YHLO Biotech Co., Ltd.·06925912718048·
PROFILER
FDA Adverse Event
BIOSITE INCORPORATED DBA INNOVACON INCORPORATED·Product code NBC·June 23, 2010
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE
FDA Adverse Event
Other
·WALLAC OY, PERKINELMER LAS·Product code JLX·March 6, 2009
DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA
FDA UDI
Diagnostics Biochem Canada Inc·B261CANP4000·For the quantitative measurement of 17α-Hydroxy...
DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA
FDA UDI
Diagnostics Biochem Canada Inc·B261CANP3200·For the quantitative measurement of 17α-Hydroxy...
N-17-OHP AccuBind ELISA Test System - 480 Wells
FDA UDI
MONOBIND, INC.·00816870021188·
N-17-OHP AccuBind ELISA Test System - 192 Wells
FDA UDI
MONOBIND, INC.·00816870021171·
N-17-OHP AccuBind ELISA Test System - 960 Wells
FDA UDI
MONOBIND, INC.·00816870021195·
N-17-OHP AccuBind ELISA Test System - 1920 Wells
FDA UDI
MONOBIND, INC.·00816870021201·
N-17-OHP AccuBind ELISA Test System - 96 Wells
FDA UDI
MONOBIND, INC.·00816870021164·
PROVENT SLEEP APNEA THERAPY
FDA Adverse Event
Malfunction
·PROVENT SLEEP THERAPY·Product code OHP·November 23, 2016
PROVENT
FDA Adverse Event
Malfunction
·VENTUS MEDICAL·Product code OHP·April 7, 2013
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
FDA Adverse Event
Injury
·VENTUS MEDICAL·Product code OHP·October 24, 2012
PROVENT SLEEP THERAPY
FDA Adverse Event
Malfunction
·PROVENT SLEEP THERAPY, LLC·Product code OHP·May 1, 2017
HANDSET FOR OSCAR II
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code JDX·April 4, 2022
2008K HEMO. SYS. OLC/DIASAFE PLUS,W/O HP
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·December 27, 2017
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 Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015
ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD)
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC.·Product code HHS·November 18, 2024