11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COLOR OPTIC CORNEAL EYE SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780456728·Integra® Jarit® Obwegeser Retractor, 70mm x 14m...
UniTip Catheter
FDA UDI
Unisensor AG·07640172971819·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971796·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971802·
IMBIBE NEEDLE
FDA 510(k)
FDA Class 1
·Orthopedic
ADT SOFT TISSUE BIOPSY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUB PEDIATRIC CRIB- HYD BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMS·May 30, 2014
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 11, 2015
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 21, 2010
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021