9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
FDA 510(k)
FDA Class 1
·Anesthesiology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916492075·Multi-Axial Cannulated Screw, Ø10.5 x 35mm, Ø6....
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471159310·SAGITTAL BLADE - DE SOUTTER STANDARD 9 x 25 x 0...
3M DISPOSABLE SKIN STAPLER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPACER-S TEMPORARY SHOULDER SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·December 5, 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