10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vu ePOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981048723·22mm Trial, 5 Deg, 11 mm
NA
FDA UDI
Exactech, Inc.·10885862524065·TRIAL, TIBIAL INSERT, SPACER, SIZE 2, SIZE 2.5,...
PCT System
FDA 510(k)
FDA Class 2
·Orthopedic
DUREPAIR DURA REGENERATION MATRIX
FDA 510(k)
FDA Class 2
·Neurology
F/G WINGSPAN STENT SYSTEM 3.0 X 20MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code NJE·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 16, 2011
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 29, 2013
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DQY·February 24, 2026
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024