BEUDAMED
    64 results · 12ms · Sources: EU EUDAMED, US FDA

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    Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

    FDA Recall
    Open, Classified ·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku·Product code IYB·October 16, 2025

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code KDD·December 16, 2025

    The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·November 15, 2023

    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Recall
    Open, Classified ·First Source Inc·Product code IZL·May 9, 2024

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Recall
    Open, Classified ·First Source Inc·Product code IZL·May 9, 2024

    Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·July 2, 2024

    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

    FDA Recall
    Open, Classified ·Keystone Industries·Product code MQC·November 20, 2023

    Speed Stitch Needle Cassette

    FDA Recall
    Open, Classified ·ArthroCare Corporation·Product code HXK·August 17, 2020

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Recall
    Open, Classified ·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021

    Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.

    FDA Recall
    Open, Classified ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·November 4, 2019

    Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code GAD·August 3, 2020

    Tibial knee prosthesis

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code JWH·July 16, 2020

    Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code JWH·September 21, 2020

    Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code MBI·March 17, 2020

    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code MAI·September 9, 2020

    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code MBI·March 17, 2020

    OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code MAI·September 9, 2020