7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURACON CONVERSION METAL BACKED PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
CELERITY 20 HP Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
BP LIMBO XL, BPTANGO XL, BP SALSA XL
FDA 510(k)
FDA Class 2
·Cardiovascular
TEMNO NEEDLE BIOPSY 22GX15CM ADJ COAXIAL
FDA Adverse Event
Malfunction
·CAREFUSION·Product code GDF·February 21, 2013
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 12, 2011
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 1, 2014
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 23, 2013