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

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    pREBOA-PRO Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMED

    FDA UDI
    Acumed LLC·10806378014246·3.5mm x 34.0mm Locking Cortical Screw

    ACUMED

    FDA UDI
    Acumed LLC·10806378014253·3.5mm x 34.0mm Locking Cortical Screw

    URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Non-contact Infrared Body Thermometer, model:HTD8823US

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PROPLEGE CORONARY SINUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·July 1, 2013

    PATIENT INTERFACE NIM4CPB1 NIM 4.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

    2124215-2011-07581

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVN·July 13, 2011

    STIMULATOR, ELECTRICAL, EVOKED RESPONSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014