51 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Access Thyroglobulin, A34085G, Catalog No. 33860
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·May 9, 2017
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·April 30, 2019
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·July 28, 2015
IMMULITE /IMMULITE 1000 TG
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·January 2, 2018
Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·October 18, 2010
IMMULITE 2000/IMMULITE 2000 XPi TG
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·January 2, 2018
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
FDA Recall
Terminated
·Carestream Health Inc.·Product code KPR·June 3, 2013
RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
FDA Recall
Terminated
·Ability Dynamics LLC·Product code ISW·June 2, 2014
Polyflex Esophageal Stent 20/16mm x 90mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Polyflex Esophageal Stent 20/16mm x 120mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·July 15, 2010
Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·May 17, 2010
Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog Number M00513810. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·May 17, 2010
Polyflex Esophageal Stent 25/21mm x 150mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
FDA Recall
Terminated
·iwalk inc·Product code ISW·October 26, 2012
Polyflex Esophageal Stent 25/21mm x 90mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Polyflex Esophageal Stent 23/18mm x 90mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/15. Catalog Number M00513830. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·May 17, 2010