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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    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

    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - 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

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code BTR·December 8, 2022

    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-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

    Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code BTR·December 8, 2022

    Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code KNW·March 8, 2021

    Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006

    FDA Recall
    Open, Classified ·Belmont Instrument LLC·Product code FRN·January 2, 2025

    Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code BTR·December 8, 2022

    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Recall
    Open, Classified ·Quest International, Inc.·Product code PCL·July 17, 2025

    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·April 28, 2025

    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·April 28, 2025