7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
FDA 510(k)
FDA Class 1
·Microbiology
EMBOSSED DISP. POLY. GLOVES #5101-03
FDA 510(k)
FDA Class 1
·General Hospital
PREMIER SELF-ETCHING ENAMEL SEALANT
FDA 510(k)
FDA Class 2
·Dental
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
DURALOC CONST LINER 56/68X32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·October 7, 2010
EVEREST INFLATION DEVICE 30ATM
FDA Adverse Event
Malfunction
·MEDTORNIC, INC·Product code DTL·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