BEUDAMED
    18 results · 21ms · 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.

    Turnpike catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE

    OPTETRAK LOGIC COMBINATION TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TREGOR DUAL MOBILITY ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OCTRODE LEAD KIT, 90CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·May 30, 2024

    OCTRODE LEAD KIT, 90CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·January 8, 2024

    OCTRODE LEAD KIT, 90CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·January 8, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON·Product code KOG·July 7, 2011

    LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 6, 2025

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025

    DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

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

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014