7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE MULTIPLE PIN PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D.O.R.C. Disposable Cryo Probe
FDA 510(k)
FDA Class 2
·Ophthalmic
MAXIMO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 5, 2012
BULLDOG
FDA Adverse Event
TELEFLEX MEDICAL·Product code GDF·September 28, 2010
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