BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Element Vascular Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982168726·WRIST FUSION PLATE 8 HOLES/SHORT BEND

    VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTETRAK HI-FLEX, PS CEMENTED FEMORAL

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code HSA·November 21, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    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