menaflex
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Biologics
Appeals court vacates FDA’s rescission of ReGen’s MenaFlex implant
September 29, 2014 by Brad Perriello A federal appeals court vacates the FDA’s decision to rescind its 510(k) clearance for…
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Regen Biologics slams FDA for revoking Menaflex approval
Regen Biologics blasted the Food and Drug Administration Monday for its decision to revoke its 2-year-old approval of the company’s…
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FDA Rescinds Approval of Menaflex Knee Replacement Device
The FDA has rescinded approval for the Menaflex Collagen Scaffold knee replacement, saying that the orthopedic implant was incorrectly fast-tracked…
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FDA: ReGen’s Menaflex data inadequate
The Food & Drug Administration said ReGen Biologics Inc. (OTC:RGBO) failed to produce adequate evidence that its Menaflex knee implant…
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