BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    CAMPYLOBACTER QUIK CHEK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

    LITE-MED LM-9200 ELMA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INCLUSIVE IMPLANT ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 6, 2024

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 6, 2013

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·July 23, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·September 19, 2008

    MPACT DOUBLE MOBILITY ACETABULAR SHELL 52

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 25, 2021

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 3, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 2, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 7, 2020

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 19, 2019

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018