7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EBNA-CHECK(TM) TEST KIT
FDA 510(k)
FDA Class 1
·Microbiology
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Apyx Plasma/RF Handpiece
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OXINIUM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·December 31, 2012
SYNCHRON® CX9 ALX CLINICAL ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·November 4, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025