7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PRECISET CHOLESTEROL HIGH PERFORM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
FDA 510(k)
FDA Class 2
·Microbiology
IMMUNETECH TOTAL IGE SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
DUAL HARMONY LIGHT
FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code FTD·January 8, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 14, 2012
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·September 3, 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