BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE

    FDA UDI
    Nuvasive, Inc.·00195377049155·PULSE Instrument Array, C

    MedGyn Pessary Cup w/support # 1

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050172·Cup Pessary is used to treat uterine prolapse.

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124795·Modular Stem 17mm x 125mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139004·

    LEAD BLOCKS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code DHA·April 10, 2013

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·May 23, 2008

    RESIDENT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 5, 2011

    Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10.

    FDA Recall
    Terminated ·Premier Dental Products Co·Product code JOH·August 5, 2004

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024