8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Amendia Interbody Fusion Devices
FDA 510(k)
FDA Class 2
·Orthopedic
JSZ MULTIACTION GP CONTACT LENS SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
TRANSVENE SVC/CS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·October 7, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 6, 2012
Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton (Product K7609), each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions Blood specimen collection
FDA Recall
Terminated
·Heritage Labs International LLC·Product code LCP·January 9, 2011
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