BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    NanoBone® SBX Putty ; NanoBone® QD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ERBE ICC 300 E

    FDA Adverse Event
    Injury ·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·September 17, 2025

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180185425·CANNULA, 5 MM DIA., 33 CM LONG, (FOR 3 MM DIA.,...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197441100·Micro Hook 90°, b...

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327029635·Tibial Bearing Insert - PS

    EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 14, 2014

    4.5MM PEEK ALLTHREAD KNOTLESS

    FDA Adverse Event
    Injury ·BIOMET SPORTS MEDICINE·Product code HWC·July 26, 2013

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code PHX·August 7, 2025

    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

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

    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