BEUDAMED
    185 results · 18ms · 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: Terminated ×

    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code DWC·July 14, 2021

    QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.

    FDA Recall
    Terminated ·Qrs Diagnostic·Product code LOS·February 16, 2012

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    FDA Recall
    Terminated ·Arc Medical Inc·Product code BYD·February 19, 2015

    Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 17, 2016

    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 17, 2016

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 14, 2015

    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Elekta Inc·May 6, 2020

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    FDA Enforcement
    Class III ·Terminated·Arc Medical Inc·May 20, 2015

    Milex Arcing Diaphragm Size 95; Model Number: MXWS95

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 16, 2016

    Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code OWB·November 3, 2015

    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code OWB·November 3, 2015

    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·May 13, 2020

    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 10, 2014

    Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code IYE·October 2, 2007

    Milex Arcing Diaphragm Size 95; Model Number: MXWS95

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HDW·February 16, 2016

    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 10, 2014

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    FDA Enforcement
    Class II ·Terminated·Omnilife Science Inc.·August 27, 2014

    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

    FDA Enforcement
    Class II ·Terminated·Omnilife Science Inc.·July 22, 2015

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.

    FDA Enforcement
    Class II ·Terminated·Orthosensor, Inc.·October 17, 2018

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

    FDA Enforcement
    Class II ·Terminated·Orthosensor, Inc.·October 17, 2018