10 results
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26ms
·
Sources: EU EUDAMED, US FDA
THE ULTRA-MATE LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981125455·4.0mm Variable Screw, Self Drilling, 18mm
E-Z Tie Tubing
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746147951·ELASTOMERIC E-Z TIE TUBING 030 GRAY 25'
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127030·
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TOMOGRAPHIC GANTRY
FDA 510(k)
FDA Class 1
·Radiology
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·March 26, 2014
PERIGEE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 29, 2012
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 30, 2010
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·March 25, 2015