8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACRODISC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ACE STAPLER AND CARTRIDGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code MSD·March 21, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 2, 2007
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018