11 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FORCEPS, BIOPSY(NON RIGID)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPTICS ONE
FDA UDI
MEDICAL TECHNIQUE, INC.·00815384020953·Zeiss MD Microscope Drape 54 x 120 w/ Krayton P...
Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)
FDA UDI
AALTO SCIENTIFIC·B085K852M200·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192244·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
Lingual Sheaths
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746133633·WELD LINGUAL SHEATH UNIV 030 W/DIST INDENT
OPTIS Mobile System
FDA 510(k)
FDA Class 2
·Radiology
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
FDA 510(k)
FDA Class 2
·Radiology
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 5, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 4, 2010
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·November 14, 2012
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020