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

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    LOBO Vascular Occlusion System (model LOBO-5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Elite HD+ Regular Body Normal Set

    FDA UDI
    ZHERMACK SPA·EZHIC2030250·Addition silicone impression material

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM

    Responsive Respiratory

    FDA UDI
    RESPONSIVE RESPIRATORY, INC.·00851440007681·25' Supply Tubing, Green

    GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

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

    SELF SEAL STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AGX

    FDA UDI
    Widex A/S·05706069719512·Audigy AGXWU-IP (Light beige ) Right

    PLATE CDC ANAEROBE 5% SB 100 EA JP

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·September 9, 2021

    PLATE CDC ANAEROBE 5% SB 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSG·June 28, 2021

    CAPSURE SENSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-REDWOOD CITY·Product code MGB·October 17, 2008

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 2, 2013

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    PLATE CDC ANAEROBE AGAR 5% SB 90MM 20

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSG·February 17, 2022

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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