8 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
CR-1
FDA 510(k)
FDA Class 2
·Ophthalmic
CARRIGEN
FDA 510(k)
FDA Class 2
·Dental
CMC LAPAROTOMY PACK
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES, INC.·Product code LRO·January 10, 2023
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·June 20, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·July 7, 2011
IITREL 3
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MEL REL·Product code LGW·September 23, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018