9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
FDA 510(k)
FDA Class 2
·Microbiology
ACUMED LASER, MODEL 1000
FDA 510(k)
FDA Class 2
·Physical Medicine
ABL90 FLEX PLUS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·January 16, 2013
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
BIGLIANI/FLATOW STEM COLLAR COUNTERBORE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·November 21, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 21, 2010
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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