12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
FDA 510(k)
FDA Class 2
·Cardiovascular
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177171·Modular Trial, 16 x 14 x 8mm, 7 Deg Lordosis
DARCO LOCKING BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Solution Set with 1.2 Micron Air Eliminating Filter
FDA 510(k)
FDA Class 2
·General Hospital
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
CLEARLINK CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
SECURA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 8, 2012
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 25, 2023
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012