9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CALCIUM HYDROXIDE MEDICAMENT
FDA 510(k)
FDA Class 2
·Dental
XLP NETWORK PRINTING
FDA 510(k)
FDA Class 1
·Radiology
TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
FDA 510(k)
FDA Class 2
·Anesthesiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2014
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 15, 2013
ADVANTA
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2010
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022