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

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    SQA V, SPERM QUALITY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MB 11

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFIED KUGEL PATCH

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

    MODIFIED KUGEL PATCH

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

    SAF-T-INTIMA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 10, 2025

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 25, 2011

    9800

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

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025