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Cowellmedi Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242287SFIT AbutmentSeptember 16, 2025
K241127INNO SLA Mini Plus® Implant SystemDecember 27, 2024
K231411INNO SLA Submerged Hybrid Ti-Base SystemDecember 20, 2023
K232546Meta G UCLA AbutmentNovember 21, 2023
K231395INNO SLA Submerged Narrow Implant SystemOctober 18, 2023
K211554InnoGenic Non-resorbable MembraneFebruary 24, 2023
K201323INNO SLA Submerged Implant SystemJanuary 25, 2022
K132242INNO SLA SUBMERGED IMPLANT SYSTEMDecember 6, 2013
K100850COWELL IMPLANT SYSTEMDecember 20, 2010
K090054ATLAS IMPLANT SYSTEM - WIDE PLUSJuly 29, 2009
K090049ATLAS IMPLANT SYSTEM- MINI PLUSApril 20, 2009
K071148ATLAS IMPLANT SYSTEMFebruary 6, 2008
K050635ALLFIM IMPLANT SYSTEMSJuly 28, 2005
K041655BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)September 8, 2004