11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBV-VCA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Pacific Blue™ Mouse IgG1, K Isotype Ctrl
FDA UDI
BIOLEGEND, INC.·00810034700728·URL: https://www.biolegend.com/en-us/products/p...
SOLUTION ADMINISTRATION, FLEX VALVE
FDA 510(k)
FDA Class 2
·General Hospital
AERO-MIST NEBULIZER
FDA 510(k)
FDA Class 2
·Radiology
PRECISION QID
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 5, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 8, 2011
STARDRIVE SCREWDRIVER SHAFT T8105MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWQ·July 1, 2016
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013