8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANS DISTAL JOINT FINGER EXTEN. SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MALLORY/HEAD - PF ACETABULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 8, 2017
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·June 10, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·December 7, 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