8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGGLUTINOTEST-ECHINOCOCCOSIS
FDA 510(k)
FDA Class 1
·Microbiology
CMDR 2CW (Multiple models)
FDA 510(k)
FDA Class 2
·Radiology
SCUTABOND
FDA 510(k)
FDA Class 2
·Dental
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 23, 2020
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 5, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 6, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025