Zimmer Medizinsysteme GmbH FDA Approvals

0 new drug approvals and 10 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
CoolTone510(k)Jan 16, 2026Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jan 16, 2026
CoolTone510(k)Jul 14, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Jul 14, 2025
PTG-05510(k)Jul 21, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jul 21, 2024
RFG-01510(k)Jul 15, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 15, 2024
MFG-05510(k)Oct 5, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 5, 2023
ThermoTK510(k)May 25, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 25, 2023
c1Trac510(k)May 16, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	May 16, 2023
CoolTone510(k)Apr 1, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Apr 1, 2022
Cryo 7510(k)Feb 4, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Feb 4, 2022
emField510(k)Feb 19, 2021Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Feb 19, 2021