8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
I.C.E. BOX
FDA 510(k)
FDA Class 2
·Physical Medicine
LASERBRUSH
FDA 510(k)
FDA Class 2
·Physical Medicine
7.0 FR. ENDOBRONCHIAL BLOCKER
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 20, 2014
LACTOSORB PECTUS STABILIZER
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·November 7, 2012
COULTER LH 780 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·August 31, 2010
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025