8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641479·OPAQUE MATERNITY 20-30 MM HG KNEE HIGH ZIG ZAG ...
MEDICON Spinal Spreading Systems
FDA 510(k)
FDA Class 2
·Neurology
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 7, 2012
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC·Product code GDW·June 5, 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