BEUDAMED
    13 results · 23ms · 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 Regulation: Us FDA ×

    Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197532150·Noyes Alligator Forceps 14cm/5 1/2" 1x2 te...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197441155·Micro Ball Dissector 90°, 3...

    Optilite IgG4 Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GATEWAY BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code GBA·November 14, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 16, 2011

    HYALURONIC ACID

    FDA Adverse Event
    Injury ·UNKNOWN·Product code MOZ·July 10, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013