10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
K2-HF DENTINE, D-D4, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621160·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862116180·Standard Band, Tooth 45/35, Size 16/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862116220·Standard Band, Tooth 45/35, Size 16/Roth 22
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
ANESTHESIA GAS MACHINE
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 7, 2012
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