Heraeus Medical GmbH FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
OSTEOPAL® V510(k)Dec 5, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 5, 2024
COPAL® exchange G hip spacer; COPAL® G+V510(k)Feb 15, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 15, 2024
COPAL knee moulds510(k)Feb 4, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 4, 2023
COPAL exchange G hip spacer510(k)Mar 23, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 23, 2022
PALACOS MV pro510(k)Feb 2, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 2, 2022
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro510(k)Jul 9, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 9, 2021