8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALBA HEALTH CARE PLAIN PACKING STRIP
FDA 510(k)
FDA Unclassified
·Unknown
KINSA SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
FDA 510(k)
FDA Class 2
·Neurology
MALLORY/HEAD - PF ACETABULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 8, 2017
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 4, 2010
*
FDA Adverse Event
MEDLINE INDUSTRIES, INC.·Product code LRO·November 27, 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