8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KBA3D
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114315·PUSH-PULL HOOK ANGLED (BX/3)
AMMONIA ASSAY FOR THE ADVIA 1650
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENEO TOTALE (Model: ENEOT947)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IDENTITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
RAPID RHINO EPISTAXIS DEVICE
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code EMX·August 18, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 10, 2013
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026