BEUDAMED
    22 results · 32ms · Sources: EU EUDAMED, US FDA

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    HS Fiber

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II

    36M - Salt River Project-31 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588022024·36M - Salt River Project-31 - Metal

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA

    POLESTAR N-10

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 28, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 11, 2011

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code EIA·October 27, 2014

    EVIS LUCERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDT·September 11, 2024

    Y-90 THERASPHERE

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·August 21, 2024

    HEALON GV PRO

    FDA Adverse Event
    Injury ·AMO UPPSALA AB·Product code LZP·October 27, 2022

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 31, 2018

    GYNECARE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·September 30, 2024

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·September 30, 2024

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·August 5, 2022

    UNKNOWN VICRYL RAPIDE SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·November 15, 2022

    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021