Nvision Biomedical Technologies FDA Approvals

0 new drug approvals and 5 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
EnHAnce PEEK Bunion System510(k)Sep 18, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 18, 2026
Impact PEEK Union Nail System510(k)Jun 11, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 11, 2025
Caliber Intramedullary Fixation System510(k)Feb 5, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 5, 2025
Trigon PEEK HA Wedges510(k)Nov 8, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Nov 8, 2024
Trigon Trigon HA Stand-Alone Wedge Fixation System510(k)Jan 26, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 26, 2024