4 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
FDA Recall
Terminated
·Bioventus, LLC·Product code MQV·February 13, 2019
EXOGEN Ultrasound Coupling Gel
FDA Recall
Terminated
·Bioventus, LLC·Product code LOF·December 17, 2020
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
FDA Enforcement
Class II
·Terminated·Bioventus, LLC·April 24, 2019
EXOGEN Ultrasound Coupling Gel
FDA Enforcement
Class II
·Terminated·Bioventus, LLC·January 20, 2021