3 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
FDA Enforcement
Class II
·Terminated·Burlington Medical, LLC·August 7, 2019
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023