10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MAGNA SURGEONS GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
"1.5MM" SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036060978·
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
FDA 510(k)
FDA Class 2
·Radiology
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·May 28, 2014
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013
DIFCO DESOXYCHOLATE AGAR
FDA Adverse Event
Other
·BD DIAGNOSTIC SYSTEMS·Product code JSG·November 24, 2010
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026