8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DISP. FLUID ISOLATOR & PRESS. RELIEF
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOBIOM SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bluetooth blood pressure monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·April 24, 2014
11.5FX20CM TRIPLE LUMEN CATH
FDA Adverse Event
Malfunction
·MEDCOMP·Product code DQO·September 28, 2012
RENEGADE¿ HI-FLO¿ FATHOM¿ KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·July 27, 2010
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024