9 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EBM IDO VIEWER
FDA 510(k)
FDA Class 2
·Radiology
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
FDA 510(k)
FDA Class 2
·Neurology
QONTRAST
FDA 510(k)
FDA Class 2
·Radiology
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 24, 2021
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 31, 2013
MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 17, 2011
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017