7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BOWEN SUTURE PASSER
FDA 510(k)
FDA Class 1
·Orthopedic
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
ACCU-CHEK LINKASSIST
FDA 510(k)
FDA Class 2
·General Hospital
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 10, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 9, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·December 10, 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