9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
RIA-120 AND ESTRIOL REAGENT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NewPort
FDA UDI
Seaspine Orthopedics Corporation·10889981148775·Navigation NewPort Tap, 6.5mm
BUSSE EPIDURAL CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
STRESS SYSTEM, 3-CHANNEL (#21127A)
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
HEARTSTART XL + DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 5, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 3, 2012
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025