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

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    SERAGAN ACTH125 I-RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788221150·Steerable IBD Trial 15x10x28, 6 deg

    CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLAGEN DENTAL WOUND DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·May 20, 2014

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 9, 2012

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·August 24, 2010

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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