11 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bioptimal Bipolar Pacing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266573·FRAZIER SUCTION TUBES 4.5" ANGLED 7 FRENCH
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920652·
Topcon Healthcare, Inc.
FDA registration
Topcon Healthcare, Inc.·9 products·🇺🇸 United States
SCENIUM
FDA 510(k)
FDA Class 2
·Radiology
Univers Rivers Shoulder Prosthesis System
FDA 510(k)
FDA Class 2
·Orthopedic
2242863-2000-00001
FDA Adverse Event
Other
·Product code HKI·May 11, 2000
UNICIRCUIT
FDA Adverse Event
Malfunction
·GE HEALTHCARE FINLAND OY·Product code CAI·November 19, 2008
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025