Beijing Fule Science & Technology Development Co., Ltd. FDA Approvals

0 new drug approvals and 4 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
Fule Vertebroplasty Balloon Catheter510(k)Aug 28, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 28, 2026
Fule Metallic Lockable Intramedullary Nail Systems510(k)Jun 17, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 17, 2026
Fule Interbody Fusion Cage System510(k)Jun 15, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 15, 2026
Fule Spinal Fixation System510(k)Oct 24, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 24, 2025