8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OverStitch SX Endoscopic Suturing System (ESS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294286·
SELF SEAL STERILIZATION POUCH
FDA 510(k)
FDA Class 2
·General Hospital
DSC/ALF SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LS LF PRIMARY I.V. SET 120IN CONV 0.2MICR
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·June 7, 2013
BECTON-DICKINSON VISITEC
FDA Adverse Event
Injury
·BECTON-DICKINSON·Product code FMI·June 5, 2006
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
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