8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ACUSON S319 TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971048·
RB12 SUCTION RECTAL BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 8, 2010
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 29, 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