8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IQ SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981720·anteriors; shade D4; mould US4
Epiphany Cardio Server Mobile
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 27, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016