BEUDAMED
    11 results · 31ms · Sources: EU EUDAMED, US FDA

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    Insure® Universal; Insure® Universal Automix

    FDA 510(k)
    FDA Class 2 ·Dental

    HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    PORCINE ANORGANIC BONE MINERAL

    FDA 510(k)
    FDA Class 2 ·Dental

    LEVEEN NEEDLE ELECTRODE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code GEI·October 18, 2017

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAN·September 9, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·July 22, 2013

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019