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

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    Tracheal Stent System

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM

    24M - Salt River Project-21 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal

    36M - Salt River Project-31 - Metal

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

    VKS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PHASEAL¿ L CONNECTOR C90J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 31, 2022

    PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD POSIFLUSH¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2023

    G7 FINNED 4 HOLE SHELL 56F

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·February 8, 2022

    BD PHASEAL¿ L CONNECTOR C90J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 16, 2022

    GORE MYCROMESH BIOMATERIAL MESH

    FDA Adverse Event
    Injury ·W.L. GORE AND ASSOCIATES·Product code FTL·August 8, 2011

    S-ICD SYSTEM

    FDA Adverse Event
    Malfunction ·CAMERON HEALTH·Product code LWS·June 28, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 16, 2008

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

    MARKED SPRING TIP GUIDEWIRE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code KNQ·November 8, 2012

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 14, 2022

    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

    Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·June 23, 2021