10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DEKNA BAND KIT
FDA 510(k)
FDA Class 1
·Physical Medicine
K2-HF DENTINE, D-D3, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621150·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862115180·Standard Band, Tooth 45/35, Size 15/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862115220·Standard Band, Tooth 45/35, Size 15/Roth 22
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
FDA 510(k)
FDA Class 2
·Anesthesiology
KETAC-CHEM
FDA 510(k)
FDA Class 2
·Dental
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·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