7 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACETABULAR DOME AND SCREW HOLE PLUGS
FDA 510(k)
FDA Class 3
·Orthopedic
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 17, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 9, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2014
MEGA 7.5FR. 40CC
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020