10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AST REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PULMOLIFE
FDA 510(k)
FDA Class 2
·Anesthesiology
TRI-CON TRIGLYCERIDGE REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code KOG·October 1, 2010
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
MICRA
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code PNJ·November 14, 2022
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DYB·November 14, 2022
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PNJ·November 14, 2022
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