107 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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Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
FDA Enforcement
Class II
·Terminated·Reckitt Benckiser LLC·March 1, 2017
Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
FDA Recall
Terminated
·Reckitt Benckiser LLC·Product code HIS·November 22, 2016
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code KPS·April 25, 2016
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAX·January 9, 2007
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·December 7, 2016
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 15, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy. .
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·August 16, 2013
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code FMF·October 20, 2017
Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
FDA Recall
Terminated
·Caridian BCT, Incorporated·Product code LKN·December 9, 2010
Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
FDA Recall
Terminated
·Caridian BCT, Incorporated·Product code LKN·September 21, 2011
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code MUU·November 3, 2016
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
FDA Recall
Terminated
·Gambro BCT, Inc.·Product code LKN·September 18, 2007
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·August 16, 2013