8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ORTHO SPECTRUM
FDA 510(k)
FDA Class 2
·Hematology
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BARD PTFE (TEFLON) COATED GUIDE WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 17, 2010
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024