8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MICRO THIN* PARAFFIN
FDA 510(k)
FDA Class 1
·Pathology
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
FDA 510(k)
FDA Class 2
·Ophthalmic
AGFA MODEL CR30-X
FDA 510(k)
FDA Class 2
·Radiology
FLEXOCRIN 4/0 (1.5) 75CM DS16
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAW·August 14, 2014
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014
PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·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