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Heraeus Medical GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K241674OSTEOPAL® VDecember 5, 2024
K234028COPAL® exchange G hip spacer; COPAL® G+VFebruary 15, 2024
K222570COPAL knee mouldsFebruary 4, 2023
K220492COPAL exchange G hip spacerMarch 23, 2022
K213812PALACOS MV proFebruary 2, 2022
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proJuly 9, 2021
K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GNovember 23, 2020
K191016COPAL exchange G Hip and Knee SpacersNovember 1, 2019
K190766PALACOS fast R+GMay 31, 2019
K182260PALACOS MVSeptember 17, 2018
K153737OSTEOPAL plusApril 22, 2016
K150119PALACOS R proJune 17, 2015
K142157PALACOS R+G PROSeptember 5, 2014