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

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    ARCOMXL ACTIVE ARTICULATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169601376·SPACER 2110555 OLIF25 20MM 0 DEG 16X55

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

    APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JAX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMISTEM H, HA COATED STEM SIZE 5 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 25, 2016

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    MAXI MOVE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·April 8, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 1, 2011

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018