7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
FDA 510(k)
FDA Class 2
·Orthopedic
MVP-10 PEDIATRIC/NEONATAL VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MED CORP·Product code MKJ·October 26, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 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