BEUDAMED
    21 results · 18ms · Sources: EU EUDAMED, US FDA

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    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code MZW·September 23, 2013

    Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants

    FDA Recall
    Terminated ·Kerr Corporation·Product code MZW·February 3, 2011

    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.

    FDA Recall
    Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code MZW·February 22, 2013

    Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    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

    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·June 17, 2024

    Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·November 4, 2021

    Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code EZW·June 25, 2007

    Medtronic InterStim Ground Pad REF 041826

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·July 6, 2023

    Enhanced Verify Evaluation Handset (CFN HH90130FA)

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·April 3, 2025

    InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·May 15, 2019

    C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CZW·May 16, 2018

    Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code EZW·May 12, 2008

    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·February 28, 2022