BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SMARTSTEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SENSITHERM PROBE

    FDA Adverse Event
    Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·June 10, 2011

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

    TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code MRG·April 19, 2018

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019