7 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALLERG*ENS ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
OP II VISIBLE LIGHT CURING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TROGIDE
FDA 510(k)
FDA Class 2
·Anesthesiology
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 12, 2010
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 9, 2012
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022