10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NO. 100352 GALVANIC OXYGEN SENSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
K2-HF DENTINE, D-C4, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621130·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862113220·Standard Band, Tooth 45/35, Size 13/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862113180·Standard Band, Tooth 45/35, Size 13/Roth 18
SOLAR REUNION FRACTURE STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Powder Free Nitrile Examination Gloves (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 7, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 8, 2010
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