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

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    FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603

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

    FUJIFILM ENDOSCOPE MODELS EC-760R-V/M

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·March 25, 2024

    MP Reconstruction System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320530·

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320578·Hip Prosthesis Stem,Size XS-5

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320547·Hip Prosthesis Stem,Size XS-2

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320585·Hip Prosthesis Stem,Size XS-6

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320561·Hip Prosthesis Stem,Size XS-4

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320509·Hip Prosthesis Stem,Size XS-0

    MP Reconstruction Prosthesis

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575320554·Hip Prosthesis Stem,Size XS-3

    G-CATH TISSUE ANCHOR DELIVERY CATHETER

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

    TRILOGY SYSTEM WITH RAPIDARC

    FDA 510(k)
    FDA Class 2 ·Radiology

    3004371426-2018-00016

    FDA Adverse Event
    Malfunction ·November 26, 2018

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 17, 2013

    EASYTRAK 2

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

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 19, 2008

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

    LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.

    FDA Enforcement
    Class II ·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019