4 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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EasyPoint Needle, 25G x 5/8", REF: 82091
FDA Enforcement
Class II
·Ongoing·Retractable Technologies, Inc.·March 20, 2024
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020