7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SURGICAL SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRI-COUNT 10
FDA 510(k)
FDA Class 2
·Hematology
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 10, 2014
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 4, 2010
ON-X MITRAL PROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·December 6, 2012
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