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

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    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·November 23, 2022

    Diowave Laser System, REF: Diowave 250W

    FDA Enforcement
    Class II ·Ongoing·Technological Medical Advancements LLC·May 20, 2026

    Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 13, 2019

    GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·May 21, 2025

    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    FDA Enforcement
    Class II ·Ongoing·REPLIGEN CORPORATION·January 21, 2026

    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT

    FDA Enforcement
    Class II ·Ongoing·Covidien LP·February 7, 2024

    GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600

    FDA Enforcement
    Class II ·Ongoing·Philips Respironics, Inc.·November 19, 2025

    Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·August 20, 2025

    Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

    FDA Enforcement
    Class II ·Ongoing·Draeger Medical Systems, Inc.·February 5, 2025

    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025

    Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025

    GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025