BEUDAMED
    24 results · 24ms · 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 ×

    HEPATIQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    Equator

    FDA UDI
    Preat Corporation·00842092183656·Equator Abutment for Astra EV 3.0 x 1mm

    APEX REVISION KNEE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA OXY-AFR SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BDRV CANN SCW SS P/T DIA4.5X60 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    BDRV CANN SCW SS P/T DIA4.5X52 MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HWC·March 7, 2017

    COREGA ULTRA

    FDA Adverse Event
    Death ·GLAXOSMITHKLINE·Product code KOL·May 30, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 21, 2011

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 29, 2020

    DYB INTRODUCER, CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 12, 2025

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·October 29, 2025

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 12, 2018

    PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·April 19, 2021

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 15, 2020

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 16, 2020

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·August 15, 2019