FH Industrie 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
JARVIS Metaphyseal Stem510(k)Jan 9, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 9, 2026
JARVIS Diaphyseal Stem Standard510(k)Oct 29, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 29, 2025
JARVIS Glenoid Reverse Shoulder Prosthesis510(k)Aug 28, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 28, 2025
JARVIS Glenoid Reverse Shoulder Prosthesis510(k)Nov 25, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 25, 2024
ARROW Off-Centred Humeral Insert510(k)Aug 29, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 29, 2023
e-Ortho Shoulder Software v1.1510(k)Sep 30, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 30, 2022
ARROW Short Stem Humeral System510(k)Nov 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 30, 2021