11 results · 6ms · Sources: EU EUDAMED, US FDA

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***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

FDA Enforcement
Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012

***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source

FDA Enforcement
Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012

Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

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

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

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 Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 19, 2016

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 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 Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 19, 2016