BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    HORIZONS HOT BIOPSY FORCEPS

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

    ProSim 8P

    FDA UDI
    FLUKE ELECTRONICS CORPORATION·00850540007225·Vital Signs Patient Simulator

    GUIDEWIRE, 3.2 x 660mm, DRILL POINT

    FDA UDI
    ORTHO OUTCOMES, LLC·00850072364162·GUIDEWIRE, 3.2 x 660mm, DRILL POINT

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    WMT MODULAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXICAST PRIME

    FDA 510(k)
    FDA Class 2 ·Dental

    IMMULITE 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Malfunction ·DAVOL INC.·Product code FTL·September 1, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 26, 2013

    KIMBERLY-CLARK MIC-KEY EXTENSION SET

    FDA Adverse Event
    Injury ·KIMBERLY-CLARK MEDICAL DEVICES·Product code KNT·March 11, 2011

    2600

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

    MAMMOGRAPHY

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·August 24, 2016

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·August 2, 2011

    CryoValve, Pulmonary Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·November 19, 2003

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024