7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
FDA 510(k)
FDA Class 2
·Anesthesiology
Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
SUBCLAVIAN
FDA 510(k)
FDA Class 2
·General Hospital
VIRTUOSO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
2520274-2012-03650
FDA Adverse Event
Injury
·SYNTHES·Product code HWC·December 7, 2012
DELTEC COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·October 4, 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