9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIOMAT 6000
FDA 510(k)
FDA Class 2
·Cardiovascular
Sunshine Diamonds
FDA UDI
Dr. Hopf GmbH & Co. KG·ESUN8602040122·Rotary diamond instruments
LIAISON EA IGG
FDA 510(k)
FDA Class 1
·Microbiology
BSD4343 Digital Flat Panel X-ray Detector
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 21, 2012
UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·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