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  • 1.  510k Transfer

    Posted 12-Nov-2019 03:28
    Can any one advise if there is any database to find 510k Transfers and Transferers list (market)?

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    Bhagya Munagoti
    QA Manager & Regulatory Lead
    Cranleigh
    United Kingdom
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  • 2.  RE: 510k Transfer

    Posted 12-Nov-2019 21:17
    Can you clarify the terminology?  Are you looking for a list of 510(k)s that have changed ownership?  Or something else?
    Thanks!
    Melissa

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    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
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    Original Message


  • 3.  RE: 510k Transfer

    Posted 13-Nov-2019 04:43
    I am looking for the list of changed ownership and also if there is any database / source where manufacturers are willing to transfer their 510(k)  ownership?

    I am sorry if I not made myself clear.

    Thanks,
    Bhagya

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    Bhagya Munagoti
    QA Manager & Regulatory Lead
    Cranleigh
    United Kingdom
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    Original Message


  • 4.  RE: 510k Transfer

    Posted 13-Nov-2019 11:21
    Bhagya,

    This does not exist.  In fact, the 510(k) database is not update with new owners or different companies for the products.  When a 510(k) is cleared, the information in the database is essentially written in "stone" meaning it is not changed.  The only way you can find the current owner of a product is from the 510(k) database, get the Product Code the device was cleared.  In most cases ... this should still be the same in the device listing database.  In the medical device listing, FURLS, you can search on the Product Code, get the product name, and then click to see who the current manufacturer or owner.  This may not always be the case because sometimes when companies buy a product (and thus the 510(k)) they may often change the product name - so it may not always be available.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: 510k Transfer

    Posted 13-Nov-2019 15:13
    Bhagya,

    Richard is right.  FDA does not update 510(k) records like they do with PMAs.  There is no nifty database or listing of changed ownership.  Because we integrate multiple FDA databases, we can run a report for you that lists the 510(k)s in the Device Listings data that have owner-operator names that are different than the Applicant of the original 510(k).  The list will not necessarily mean that all of them were sold to another entity.  Company names change and mergers happen, which would also be included in the list.  If you are interested in some particular kind of product, like a particular code, we can give you that subset as well.  

    If this is something you would like to have, let me know.  We can chat about the specifics of what might be helpful for you.

    Cheers,
    Melissa

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    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
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    Original Message


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