8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACUSON S519 TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
CYNERGY MODEL 184
FDA 510(k)
FDA Class 2
·Cardiovascular
CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWB·October 19, 2016
EON
FDA Adverse Event
Death
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 23, 2014
VIRTUOSO II DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 28, 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