7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
WHITE OAK ALLERGEN DISC
FDA 510(k)
FDA Class 2
·Immunology
CRYOCARE CN2 SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
FDA 510(k)
FDA Class 1
·General Hospital
THINLINE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 8, 2010
MAQUET HCU30 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWC·March 4, 2014
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MTA·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