8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
FDA 510(k)
FDA Class 2
·Immunology
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
FDA 510(k)
FDA Class 2
·Cardiovascular
ZONA PLUS
FDA Adverse Event
Injury
·ZONA HEALTH·Product code BXB·March 25, 2013
OPTA PRO PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LIT·February 22, 2013
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
JAEYONG·Product code INM·August 4, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020