7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CASTLE 7538 FLOOR LOADING WASHER
FDA 510(k)
FDA Class 2
·General Hospital
I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT)
FDA 510(k)
FDA Class 2
·Anesthesiology
IQPACS
FDA 510(k)
FDA Class 2
·Radiology
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
FLEX 60 ENDO LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 7, 2010
CORTRAK ENTERAL FEEDING TUE
FDA Adverse Event
Other
·CORPAK MEDSYSTEMS·Product code KNT·November 8, 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