BEUDAMED
    394 results · 19ms · Sources: EU EUDAMED, US FDA

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    Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100

    FDA Recall
    Terminated ·ConMed Corporation·Product code LXH·November 12, 2020

    Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

    FDA Recall
    Terminated ·ConMed Corporation·Product code LXH·November 12, 2020

    KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.

    FDA Recall
    Terminated ·ConMed Corporation·Product code LXH·March 26, 2021

    INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling.

    FDA Recall
    Terminated ·ConMed Corporation·Product code LXH·March 26, 2021

    GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IWE·January 26, 2011

    GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi, and Signa Nvi. The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IWE·September 15, 2011

    GE Discovery MR950 MRI system

    FDA Recall
    Terminated ·GE Healthcare·Product code IWE·October 24, 2014

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    FDA Recall
    Open, Classified ·Omega Medical Imaging, Inc.·Product code IWE·September 8, 2023

    Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

    FDA Recall
    Open, Classified ·Omega Medical Imaging, Inc.·Product code IWE·February 28, 2023

    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

    FDA Recall
    Terminated ·Omega Medical Imaging, Inc.·Product code IWE·March 23, 2017

    Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IWE·September 1, 2009

    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

    FDA Recall
    Open, Classified ·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IWE·August 27, 2025

    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

    FDA Recall
    Open, Classified ·Product code KWS·August 4, 2023

    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

    FDA Recall
    Open, Classified ·Product code LZO·August 4, 2023

    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

    FDA Recall
    Open, Classified ·Product code JWH·August 4, 2023

    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

    FDA Recall
    Open, Classified ·Product code KWA·August 4, 2023

    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101

    FDA Recall
    Open, Classified ·Product code PHX·August 4, 2023

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code KOD·September 20, 2022

    Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021