12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OSSEODENT DRILLING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Signature
FDA UDI
SILEX MEDICAL, LLC·B33158621100·Glassman Grasper 10MM
Signature
FDA UDI
SILEX MEDICAL, LLC·B3315862110·Locking 10MM Glassman Grasping Forceps
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177423·Modular Trial, 14 x 13 x 10mm, 10 Deg Lordosis
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862110180·Standard Band, Tooth 45/35, Size 10/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862110220·Standard Band, Tooth 45/35, Size 10/Roth 22
CORGRIP NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTEBRON SCP CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYB·December 7, 2012
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