BEUDAMED
    257 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 ×

    NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.

    FDA Recall
    Terminated ·Cardinal Health NeuroCare Division·Product code GWQ·June 13, 2008

    Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T). Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations.

    FDA Recall
    Terminated ·Stellate Systems·Product code GWQ·April 16, 2009

    Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia

    FDA Recall
    Terminated ·Compumedics Usa, Ltd·Product code GWQ·February 24, 2005

    NicoletOne photic adapter cable 085-463700

    FDA Recall
    Terminated ·Cardinal Health NeuroCare Division·Product code GWQ·June 5, 2008

    Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

    FDA Recall
    Terminated ·Bio-Logic Systems Corp·Product code GWQ·July 26, 2007

    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

    FDA Recall
    Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015

    Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier.

    FDA Recall
    Terminated ·Compumedics Usa, Ltd·Product code GWQ·February 24, 2005

    Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG)

    FDA Recall
    Terminated ·Bio-Logic Systems Corp·Product code GWQ·February 26, 2007

    Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711

    FDA Recall
    Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·September 11, 2007

    LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252

    FDA Recall
    Terminated ·LeMaitre Vascular, Inc.·Product code DWQ·February 24, 2015

    ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

    FDA Recall
    Terminated ·LIFELINES NEURO COMPANY·Product code GWQ·October 11, 2019

    NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.

    FDA Recall
    Terminated ·CareFusion·Product code GWQ·March 8, 2010

    Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.

    FDA Recall
    Terminated ·Smith & Nephew, Inc Endoscopy Division·Product code DWQ·October 12, 2004

    Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code GWQ·October 15, 2007

    NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.

    FDA Recall
    Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·August 25, 2006

    Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,

    FDA Recall
    Terminated ·Stellate Systems·Product code GWQ·April 6, 2009

    Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726 BIPOLAR LINER 47MM OD X 2 500104732 BIPOLAR LINER 47MM OD X 3 500105028 BIPOLAR LINER 50/51/52MM 500105022 BIPOLAR LINER 50MM OD X 2 500105026 BIPOLAR LINER 50MM OD X 2 500105328 BIPOLAR LINER 53/54/55MM 500105322 BIPOLAR LINER 53MM OD X 2 500105326 BIPOLAR LINER 53MM OD X 2 500105728 BIPOLAR LINER 57/58MM OD 500105722 BIPOLAR LINER 57MM OD X 2 500106028 BIPOLAR LINER 60/62MM OD 500106828 BIPOLAR LINER 68/70MM OD 500106832 BIPOLAR LINER 68MM OD X 3 500107228 BIPOLAR LINER 72MM OD X 2 500103800 BIPOLAR SHELL 38MM OD 500103900 BIPOLAR SHELL 39MM OD 500104000 BIPOLAR SHELL 40MM OD 500104100 BIPOLAR SHELL 41MM OD 500104200 BIPOLAR SHELL 42MM OD 500104300 BIPOLAR SHELL 43MM OD 500104400 BIPOLAR SHELL 44MM OD 500104500 BIPOLAR SHELL 45MM OD 500104600 BIPOLAR SHELL 46MM OD 500104700 BIPOLAR SHELL 47MM OD 500104800 BIPOLAR SHELL 48MM OD 500104900 BIPOLAR SHELL 49MM OD 500105000 BIPOLAR SHELL 50MM OD 500105100 BIPOLAR SHELL 51MM OD 500105200 BIPOLAR SHELL 52MM OD 500105300 BIPOLAR SHELL 53MM OD 500105400 BIPOLAR SHELL 54MM OD 500105500 BIPOLAR SHELL 55MM OD 500105700 BIPOLAR SHELL 57MM OD 500105800 BIPOLAR SHELL 58MM OD 500106000 BIPOLAR SHELL 60MM OD 500106200 BIPOLAR SHELL 62MM OD 500107000 BIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016