BEUDAMED
    31 results · 25ms · Sources: EU EUDAMED, US FDA

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    Transcutaneous Electrical Nerve Stimulator (K6106)

    FDA 510(k)
    FDA Class 2 ·Neurology

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517443526·SpheRx® II Lamina Hook, 6mm Ext Narrow

    CAMERA ENABLED PROBE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Widex

    FDA UDI
    Widex A/S·05706069908138·WIDEX MOMENT MRB2D DEMO (Silver Grey ) 440, Tel...

    Widex

    FDA UDI
    Widex A/S·05706069828139·WIDEX EVOKE EBB3D DEMO (Silver Grey ) 440, Tele...

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·KENVUE·Product code KGX·October 8, 2025

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWE·November 10, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 17, 2011

    LUMAX 540 DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·July 22, 2013

    LOCAL ANESTHESIA CUSTOM PACK

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BSO·March 31, 2025

    BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·June 12, 2024

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

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

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025