7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MARDIS DANGLER URETERAL STENT SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECICE Trauma Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
PONTO WIDE IMPLANT WITH ABUTMENT
FDA Adverse Event
Other
·OTICON MEDICAL AB·Product code LXB·November 23, 2012
ADVIA 2400
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 22, 2015
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