8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DELFIA (TM) HUMAN PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640397·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
MGN SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
PCA EMPTY STERILE
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·November 28, 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