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

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    ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ITOTAL OVAL PATELLA TRIAL 32MM

    FDA UDI
    Conformis, Inc.·00810933030414·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110986·LOCATOR R-Tx Abutment for 4.3mm Camlog Connecti...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114595·LOCATOR F-Tx Abutment for 4.3mm CAMLOG Connecti...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450047583·

    SYRINGE 50ML LL TIP 1ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·July 8, 2024

    CORTEK LAPAROSCOPES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FMF·July 9, 2024

    EMAX2PLUS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015

    ATLAS II VR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·April 6, 2011

    CD1800 ANALYZER

    FDA Adverse Event
    Injury ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·July 22, 2008

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·May 4, 2016

    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·March 25, 2026