10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STICKY WAX
FDA 510(k)
FDA Class 1
·Dental
KAPPER
FDA 510(k)
FDA Class 2
·Dental
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 30, 2024
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·February 11, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 10, 2011
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·July 24, 2014
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 30, 2024
BD BACTEC PEDS PLUS/ F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 14, 2021
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020