BEUDAMED
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    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code MFK·July 26, 2022

    Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

    FDA Recall
    Terminated ·Solta Medical, Inc.·Product code ONG·December 15, 2010

    Catgut GmbH

    Importer
    🇩🇪 Germany·5 Manufacturers

    Duomed Belgium NV

    Importer
    🇧🇪 Belgium·62 Manufacturers

    RIOMAVIX LTD

    Authorized representative
    🇪🇸 Spain·400 Manufacturers·4531 Devices

    Overpharma - Produtos Médicos e Farmacêuticos, Lda.

    Importer
    🇵🇹 Portugal·16 Manufacturers