9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HYGEIA RAPID STREP A TEST
FDA 510(k)
FDA Class 1
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707059035·DB TUBE EXTREMO NO-Ni 22 T-14 R+8 UL
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VerteFIT Corpectomy Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
VERTE-STACK® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·October 7, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
CARDIOSAVE
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