8 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYCEL M
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Quick coupling
FDA UDI
SIRONA Dental Systems GmbH·E2767903351·5-Hole Coupler, K-style
GSP Neonatal Total Galactose kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HD GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 15, 2012
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code HXX·August 5, 2010
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018