14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Esperance Distal Access Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Unity Total Knee System
FDA UDI
CORIN LTD·05056139233104·Unity ASC Size 6 Tibial Template Trial
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001424·Symmetry® Curette, Spinal, Angled, Size 3, 8 in...
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
NeuroBlate System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFINITY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·May 27, 2024
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·February 24, 2025
INFINITY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·March 2, 2025
SUPERDIMENSION BRONCHUS SYSTEM (SDBS)
FDA Adverse Event
Malfunction
·SUPERDIMENSION INC.·Product code JAK·October 30, 2008
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 20, 2011
PCA ST EMPTY VIAL
FDA Adverse Event
Malfunction
·HOSPIRA INC., HOSPITAL PRODUCTS DIVISION·Product code MEA·July 12, 2013
INFINITY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·September 27, 2024
CD HORIZON SOLERA 4.75
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·February 13, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025