8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DAKO ITA SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973202·
MODIFIED MERCI RETRIEVER, MODEL 90092
FDA 510(k)
FDA Class 2
·Cardiovascular
MALE URINARY CATHETER, EXTERNAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·April 14, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·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