13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMULITE PYRILINKS-D
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CORAIL
FDA UDI
DEPUY (IRELAND)·10603295478690·CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA CO...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293357·
Tx™
FDA UDI
INNO Holdings, Inc.·M711LS39713120·Ti 6Al 4V (ELI)
BLOOD UREA NITROGEN (BUN) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FortiCore®
FDA 510(k)
FDA Class 2
·Orthopedic
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021142797131217201·BTE-TRT
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
ELECTRONIC FOOT CONTROL W/DIR ONLY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 31, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·April 17, 2008
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