7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
IONIZED CALCIUM AND BLOOD PH TESTCARDS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Electrosurgical Generator ESG-200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FILTER SET, PMF 2028
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
CE INTERMATE, SV 200, 24 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 7, 2010
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MED CORP·Product code MKJ·October 26, 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