BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FUJIFILM BALLOON BS-4

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDA·January 14, 2021

    TUBULAR PLATE

    FDA UDI
    Biomet Orthopedics, LLC·00887868004506·

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 28, 2014

    IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 6, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 2, 2011

    NEEDLE 19G 1-1/2IN TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·April 21, 2020

    PKG, BLAKESLY BIOPSY FORCEPS, P/N 0250080292. 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

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017