7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLENROE CHAIN
FDA 510(k)
FDA Class 1
·Dental
API UNISCEPT PLUS 140 INOCULATOR
FDA 510(k)
FDA Class 1
·Microbiology
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART XL+ DEFIBRILALTOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 14, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 28, 2013
PUMP MMT-712NAS PRDGM INSULIN SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·December 8, 2010
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025