38 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Advanced LumFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOCORD HEALIX BR
FDA UDI
Medos International Sàrl·10886705007769·HEALIX BR Anchor w/ORTHOCORD TCP/PLGA Absorbabl...
LCP
FDA UDI
Synthes GmbH·10886982156693·LCP PROXIMAL LATERAL TIBIA PLATE 13 HOLES/300MM...
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VICEROY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK MANUFACTURING·Product code KWQ·March 23, 2010
UNK
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code MCV·March 23, 2010
UNK
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code MCV·March 23, 2010
UNK
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code MCV·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 23, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 12, 2013
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 18, 2025