7 results
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18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
FDA 510(k)
FDA Class 2
·Immunology
EKG ELECTRODES, DISPOSABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
QUANTROLS RF
FDA 510(k)
FDA Class 2
·Immunology
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 17, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 16, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015