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

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    P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)

    FDA 510(k)
    FDA Class 2 ·Dental

    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·July 20, 2022

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 9, 2024

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·April 22, 2013

    IN TOUCH EU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 29, 2011

    CAPTIVATOR II

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FDI·July 7, 2008

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 11, 2024

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 28, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024