BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Playtex Stella Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·September 29, 2008

    PEDIASAT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    TFNA FEM NAIL Ø10 R 125° L320 TIMO15

    FDA Adverse Event
    Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018

    10MM/125 DEG TI CANN TFNA 200MM - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018