BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BI-METRIC X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304182714·

    Empower Clear

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746000171·COSMETIC SL EMPOWER CLEAR INTERACT UR CUSPID 01...

    BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNILUX CLEAR-U

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REFLEXION¿ SPIRAL EP CATHETER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code DRF·May 31, 2019

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER

    FDA Adverse Event
    Injury ·VENUSA DE MEXICO S.A. DE C.V.·Product code OAE·May 31, 2019

    THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code OAD·May 31, 2019

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·June 12, 2013

    ISYMM ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·July 8, 2011

    SOFTCLIX LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 23, 2008

    SHAFT FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·May 10, 2019

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    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