7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HOSPITAL BED CLOTHING CRADLE
FDA 510(k)
FDA Class 2
·General Hospital
BINAXNOW STREP PNEUMONIAE 22T (LFR)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code GTZ·May 23, 2025
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
FDA 510(k)
FDA Class 2
·Immunology
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
COULTER AC*T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·October 26, 2010
FEMORAL IMPACTOR EXTRACTOR
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 14, 2012