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

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    7410 Ultrasound System (MyLabSigma)

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CABLE TENSIONER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·October 15, 2015

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·October 21, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 29, 2011

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LPH·October 15, 2025

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023