76 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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VZV IgG ELISA 96 Well Kit, Catalog Number: VZ081G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LFY·August 27, 2008
Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285
FDA Recall
Terminated
·Diasorin Inc.·Product code LFY·September 10, 2003
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
FDA Recall
Terminated
·bioMerieux, Inc.·Product code LFY·December 10, 2019
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 14, 2018
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 15, 2015
Sterile, Drape, Headset, Lower, Part Number 888944-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
Sterile, Drape, Headset, Upper, Part Number 888945-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016
Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients
FDA Enforcement
Class II
·Terminated·Covidien LLC·March 30, 2016