8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113417·IMPLANT KNIFE 5.2MM (BX/5)
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102794·KOCH NUCLEUS CHOPPER ANGLED
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
FDA 510(k)
FDA Class 2
·Anesthesiology
TOTALSHIELD SURGICAL HELMET SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
UMBILI-CATH
FDA Adverse Event
Malfunction
·UTAH MEDICAL PRODUCTS·Product code FOS·May 15, 2013
S-ICD SYSTEM
FDA Adverse Event
Malfunction
·CAMERON HEALTH·Product code NVY·August 26, 2014