9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BCYE, SELECTIVE (W/MPA)
FDA 510(k)
FDA Class 1
·Microbiology
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457210115·Internal Hex "Click"
PC ECG 1200W SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIWay Endonasal Access Guide
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014
FR2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 20, 2010
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 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
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025