15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
FDA Recall
Terminated
·Lemaitre Vascular, Inc.·Product code DXT·July 18, 2007
Truth Renew Plus
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Truth Renew
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Ultra Renew Plus
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Ultra Renew
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
FDA Recall
Terminated
·NERL Diagnostics Corporation·Product code JWX·January 15, 2010
Truth Renew Plus
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Ultra Renew Plus
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Truth Renew
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Ultra Renew
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.
FDA Recall
Terminated
·Infantino LLC·Product code MEF·January 6, 2014
Pall Total Nutrient Admixture Filter, 1.2 micron filter This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
FDA Recall
Terminated
·Pall Life Sciences Puerto Rico Llc
Pall Blvd 99 & 100
Rd 194, Km 0.4
Fajardo PR 00738·Product code FPB·June 15, 2011
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 22, 2020
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 22, 2020
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PAM·September 5, 2018