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

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    cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Tissue Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112847·BARRON ARTIFICIAL ANTERIOR CHAMBER

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 24, 2022

    VISICOIL MR

    FDA UDI
    Izi Medical Products, LLC·B887SNMR03502022150·0.35mm x 2.0cm VISICOIL MR Platinum loaded in a...

    VISICOIL MR

    FDA UDI
    Izi Medical Products, LLC·EIBASNMR03502022150·0.35mm x 2.0cm VISICOIL MR Platinum loaded in a...

    KIRSCHNER WIRES, STEINMAN PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYRINGE 1ML 31G 8MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 29, 2021

    FOX SV PTA CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·October 16, 2008

    SPRINT QUATTRO SECURE

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

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013

    PUMP MMT-1781K 670G V4.11 MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 8, 2022

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    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