BEUDAMED
    15 results · 31ms · 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 ×

    FilmArray 2.0 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAXIM VI KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304205864·

    MAXIM® VI KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00887868225932·

    GRANTALDER RHAPSODY ACCESS PORT AND CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STRYKER VENOM ELECTRODES AND CANNULAE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PEDICLE SCREW 9X60MM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·August 9, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014

    IDENTITY ADX SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    ALARIS PUMP MODULE

    FDA Adverse Event
    Injury ·CAREFUSION CORPORATION·Product code FRN·May 24, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·June 16, 2011

    Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014