7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PULSATILE ANTI-EMBOLISM SYS.PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANGLED TAPERED ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 1, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
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