8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
FDA 510(k)
FDA Class 1
·Microbiology
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981137489·DTS Drill, 12mm
XERORADIOGRAPHY 125 SYSTEM - MODIFIED
FDA 510(k)
FDA Class 2
·Radiology
BIO 1-KIT BIOSORB FILLED CARTRIDGE
FDA 510(k)
FDA Class 2
·Orthopedic
WHISPERVIEW
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 21, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
ACCU-CHEK INFUSION SET
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·December 3, 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