10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOTROL UIBC REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909127952·REVELATION DIAMOND 855-025C - 5 PACK
PALTOP DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 14, 2014
FASHION ARM SLING, LARGE BOX 10
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code ILI·January 8, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·November 3, 2010
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021