59 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code FZT·April 24, 2008
Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
FDA Recall
Terminated
·Maquet Cardiovascular·Product code FZT·June 4, 2010
ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code FZT·April 24, 2008
ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code FZT·April 24, 2008
ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code FZT·April 24, 2008
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
FDA Recall
Terminated
·Neuro-Fitness LLC·Product code JXK·October 29, 2007
GE Healthcare Discovery NM/CT 670 CZT X-ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
FDA Recall
Terminated
·Miami Fat Supply, Inc·Product code MUU·April 21, 2016
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
FDA Enforcement
Class II
·Terminated·Miami Fat Supply, Inc·June 22, 2016
NM/CT 870 CZT Model # H3906CW
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 CZT Model # H3906CW
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·September 30, 2020
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019
GE Healthcare Discovery NM/CT 670 CZT X-ray system
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·May 19, 2017
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·March 20, 2019
Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·September 8, 2003
Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·September 8, 2003
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code N/A·June 1, 2017
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
FDA Recall
Terminated
·Shippert Medical Technologies·Product code KYZ·June 1, 2017