8 results
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20ms
·
Sources: EU EUDAMED, US FDA
ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
FDA 510(k)
FDA Class 1
·Physical Medicine
RADIOASSAY FOR TOTAL SERUM THYROXINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
FDA 510(k)
FDA Class 1
·General Hospital
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 28, 2014
PRISM HCV
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MZO·October 25, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 19, 2012
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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