FDA Product Code OEW: Tracking, Soft Tissue, Intraoperative
For Open Liver Surgical Procedures Where Image-guidance May Be Appropriate And Where The Patient Can Tolerate Long Apneic Periods Under General Anesthesia.
Leading manufacturers include Pathfinder Therapeutics, Inc. and Cascination AG.
4
Total
4
Cleared
197d
Avg days
2007
Since
FDA 510(k) Cleared Tracking, Soft Tissue, Intraoperative Devices (Product Code OEW)
4 devices
Cleared
Apr 28, 2015
CAS-One Liver
Cascination AG
General & Plastic Surgery
189d
Cleared
Feb 09, 2011
EXPLORER LIVER (PASSIVE TRACKING)
Pathfinder Therapeutics, Inc.
General & Plastic Surgery
210d
Cleared
Mar 30, 2010
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
Pathfinder Therapeutics, Inc.
General & Plastic Surgery
140d
Cleared
Dec 20, 2007
LINASYS
Pathfinder Therapeutics, Inc.
General & Plastic Surgery
248d