Synthes GmbH FDA Approvals

0 new drug approvals and 7 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
DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System510(k)Mar 10, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 10, 2026
DePuy Synthes VOLT Proximal Tibia 3.5 Plating System510(k)Mar 9, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 9, 2026
VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System510(k)Mar 2, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 2, 2026
Synthes Patient Specific Implants510(k)Nov 12, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2025
Synthes Graphic Case & Tray System510(k)Mar 28, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 28, 2025
VOLT Proximal Humerus 3.5 Plating System510(k)Jul 26, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 26, 2024
DePuy Synthes MatrixSTERNUM Fixation System510(k)May 9, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 9, 2024