8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOJECT PHARMACY TRAY
FDA 510(k)
FDA Class 2
·General Hospital
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEMOSIL SYNTHASIL
FDA 510(k)
FDA Class 2
·Hematology
LIFECARE PCA 3 V5.06
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·April 15, 2014
EVA BAG-500ML
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SAO PAULO·Product code BTC·October 7, 2010
LINOX S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·October 29, 2012
MILAGRO ADVANCE SCREW 9X30MM
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·January 23, 2019
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