9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced RNA POL III Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
FDA 510(k)
FDA Class 2
·Immunology
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·October 11, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 13, 2012
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
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017