BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    SIMDA Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517579072·CoRoent Ant TLIF Ti, 15x12x32mm 0°

    Autoimmune EIA

    FDA UDI
    BIO-RAD LABORATORIES, INC.·00847817018534·Autoimmune EIA Anti-Saccharomyces Cerevisiae An...

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041899·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041950·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041882·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041929·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041936·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041905·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041943·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041875·

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024041912·

    ENCORE CLP OFFSET TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

    FDA 510(k)
    FDA Class 2 ·Neurology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 14, 2014

    PARIETEX UGYTEX PP 15X10CM X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·July 23, 2013

    Allura Xper FD20/15; System Code: 722058;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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