12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTROL SERA LEVEL VALUES (MG/DL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOHORIZONS CERAMIC ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
SIGNA Voyager
FDA 510(k)
FDA Class 2
·Radiology
FLOEY CATHETER W TEMP
FDA Adverse Event
Injury
·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017
VIVA XT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NIK·June 10, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 7, 2012
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018
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