13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
KHURI REGIONAL TISSUE PH MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
K2-HF DENTINE, D-D2, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621140·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862114180·Standard Band, Tooth 45/35, Size 14/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862114220·Standard Band, Tooth 45/35, Size 14/Roth 22
Photon, Photon Plus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CERULOPLASMIN, MODEL 2055953
FDA 510(k)
FDA Class 2
·Immunology
MALLORY/HEAD - PF ACETABULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 8, 2017
SIGMA 200 DR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·June 10, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 8, 2010
PROMUS ELEMENT ¿ LONG
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 7, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 23, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 23, 2017
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012