4 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Mexico
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BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
FDA Enforcement
Class II
·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016
US19/819943658
Certificate
MDD Annex II (excluding section 4)·Surgical Specialties Mexico S. DE R.L. DE C.V.·SGS Belgium NV·37 Basic UDI-DIs
US19/819943622
Certificate
MDD Annex II Section 4·Surgical Specialties Mexico S. DE R.L. DE C.V.·SGS Belgium NV·146 Basic UDI-DIs
US19/819943623
Certificate
MDD Annex II Section 4·Surgical Specialties Mexico S. DE R.L. DE C.V.·SGS Belgium NV·114 Basic UDI-DIs