7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DR.500O OPERATING TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ABL300 ACID BASE LABORATORY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADULT INCONTINENCE PAD
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·June 10, 2014
ENTERRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·October 7, 2010
LIFELINE AED
FDA Adverse Event
DEFIBTECH, LLC·Product code MKJ·December 5, 2012
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