7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TELEFLEX TEFLON COATED GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
X5 Digital Color Doppler Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
AUTOFUSER
FDA 510(k)
FDA Class 2
·General Hospital
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·November 29, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·September 22, 2010
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