BEUDAMED
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    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

    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

    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

    Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005

    Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005

    Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNL·January 1, 2006

    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

    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

    EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

    FDA Recall
    Terminated ·Oak Tree International Holdings, LLC, Inc.·Product code NBW·May 26, 2009

    Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.

    FDA Recall
    Terminated ·Abbott Molecular·Product code LSK·December 20, 2010

    Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 3, 2009

    Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MKT·December 20, 2010