79 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·March 25, 2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·March 25, 2015
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Recall
Terminated
·Nidek Inc·Product code GEX·May 16, 2014
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·August 20, 2014
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
FDA Recall
Terminated
·Medical Information Technology, Inc.·Product code JQP·February 21, 2014
ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014
Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014
ADVIA Centaur HBc IgM
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018
ADVIA Centaur¿ HBc IgM
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LOM·September 15, 2014
ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LOM·September 15, 2014
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics, Inc.·November 24, 2021
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
FDA Recall
Terminated
·Bio-Rad Laboratories·January 7, 2008
TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa Canada Ontario·Product code NAW·February 24, 2009
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·September 5, 2007
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
FDA Recall
Terminated
·Ortho-Clinical Diagnostics, Inc.·Product code JJX·October 15, 2021