8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INJET-100, FLUID INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640717·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
DORA Tubing Sets for Hemodialysis
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VARISOURCE 200 HDR AFTERLOADER
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
VIRTUOSO DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·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